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General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. Develops, modifies, documents and directs the implementation and evaluation of quality assurance programs and systems on one or more mid-size to large projects. Provides expertise and guidance in interpreting quality standards and government regulations. Collaborates with engineering and manufacturing to ensure quality standards are in place. Works on moderately complex and diverse problems where analysis of situations or data requires in-depth evaluation of various factors. DUTIES AND RESPONSIBILITIES: Develops, documents and directs the implementation and evaluation of quality assurance programs and systems on one or more large projects. Provides expertise and guidance in interpreting national and international quality standards and government regulations. Consults with engineering and manufacturing to ensure quality standards are in place. Works on highly complex and diverse problems where analysis of situations or data requires in-depth evaluation of various factors. Familiarity with unreleased parts is desirable. Identifies and recommends design or manufacturing changes and enhancement. Reads and interprets engineering drawings and schematics, including drawings created utilizing GD&T principles and associated standards, i.e., ASME Y14.5. Determines technical objectives for quality assurance as well as approaches to completing projects. Creates or recommends design, dimensional or manufacturing process changes to improve products and reduce costs. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Participates in functional testing and/or inspection of equipment and systems. Audits quality systems for deficiency identification and correction. Implements solutions to complex problems occurring internally and at vendor facilities. May prepare statistical analysis reports, specifications and other technical documents. Interprets and adapts quality standards and government regulations. Acts as company contact with suppliers, customers and regulatory personnel to resolve quality issues. Delivers technical presentations. Provides project direction to other staff members. In some business units, resolves, communicates and tracks non-conformance, material rejection and corrective action reports and chairs material review board. May also perform internal company audits and conduct vendor qualification examinations. Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. Other duties as assigned or required. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job Qualifications Typically requires a bachelor's or master's degree in engineering or related discipline and six or more years of related experience with a bachelor's degree or four or more years with a master's degree. May substitute equivalent experience in lieu of education. Must be able to apply a detailed understanding of inspection methods and have strong knowledge of computer operations and applications. Must have a strong knowledge of concepts, techniques, and methods in a particular field of specialization. Must have the analytical ability required to develop creative solutions to complex quality issues and the skills required to present those solutions to internal and external contacts. Must be detail-oriented to accurately prepare statistical reports and technical documents in support of company objectives. Must have strong leadership skills to direct staff members and ensure project costs and schedules are maintained while representing the organization on technical quality assurance issues. Manufacturing or quality background in aviation is preferred. The ability to obtain and maintain a DoD security clearance will be required. Job Category Quality Experience Level Mid-Level (3-7 years) Workstyle Onsite Full-Time/Part-Time Full-Time Salary Pay Range Low 89,180 Pay Range High 155,825 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? Desired Clearance Level Secret Search Jobs at | General Atomics and Affiliated Companies
Job Title: Quality Engineer Company: One Stop Systems, Inc. (NASDAQ: OSS) Headquarters Location: Escondido/San Diego, CA Why Join Us? At One Stop Systems, we are committed to innovation and excellence. Join our team and contribute to cutting-edge projects in a dynamic and supportive environment. Company Overview: One Stop Systems, Inc. (Nasdaq: OSS) is a San Diego-based publicly traded technology company and global leader in enterprise class compute solutions for AI/ML, sensor fusion, and autonomy at the demanding ‘edge.’ OSS designs and manufactures the highest performance compute and storage products that enable these rugged AI, sensor fusion and autonomous mobile capabilities without compromise. These hardware and software platforms bring the latest enterprise class data center performance and technology to the harsh and challenging applications, whether they are on land, sea or in the air. OSS products include ruggedized servers, compute accelerators, flash storage arrays, and storage acceleration software. These specialized rugged and compact products are used across multiple industries and applications, including commercial autonomous applications, as well as aircraft, drones, ships, and vehicles within the defense industry. The company has annual sales in excess of $40 million, is profitable, cash flow positive, enjoys a solid cash position without domestic debt and has target growth plans in excess of 20% a year. Our markets have significant tail winds being driven by the high priority within the DOD to add AI and/or Autonomous capabilities throughout the military theater as well as strong economic pull within the commercial segment. The market opportunity for OSS types of products is expected to grow to over $2 billion in size. Compensation & Benefits: Annual salary range $85,000 - $97,000 Potential for Stock Equity 401K Matching Competitive Benefits Package including Medical, Dental, and Vision Three weeks of PTO 11 Paid Holidays Position Overview: OSS is seeking a hands-on, detail-oriented Quality Engineer with three to five years of relevant experience to support product, process, supplier, and quality-management-system performance in an AS9100D-certified manufacturing environment. This mid-level position combines inspection and product assurance with root-cause analysis, corrective action, supplier quality, audit support, quality metrics, and continuous improvement. The Quality Engineer will independently handle routine quality-engineering activities, contribute to cross-functional problem solving, and receive guidance from the Quality Manager on complex, high-risk, or customer-sensitive issues. Reporting Relationships: The Quality Engineer will report to the Quality Assurance Manager. Duties and Responsibilities: Receiving and Final Inspection Perform receiving, in-process, and final inspections and support the preparation and review of First Article Inspections and First Article Inspection Reports (FAIRs) in accordance with AS9102. Inspect electro-mechanical parts and assemblies, sheet metal and machined components, printed circuit boards (PCBs), printed circuit board assemblies (PCBAs), and related hardware. Interpret engineering drawings, specifications, tolerances, geometric dimensioning and tolerancing (GD&T), surface-finish requirements, workmanship standards, and customer quality notes. Perform visual inspections of plating, coatings, chemical conversion coatings, paint, cosmetic surfaces, soldering, conformal coating, and other applicable finishes or special processes. Select and use appropriate inspection equipment, including calipers, micrometers, height or drop gages, pin gages, thread gages, go/no-go gages, microscopes, surface plates, and other precision measuring tools. Ensure inspection records, reports, and related documentation are complete, accurate, traceable, and processed in a timely manner. Product Quality and Manufacturing Support Assist with the development, implementation, and maintenance of inspection plans, control plans, sampling plans, acceptance criteria, and inspection methods; independently maintain assigned inspection documentation. Support production-floor quality issues, monitor First Pass Yield (FPY), and help improve manufacturing quality throughout the production cycle. Nonconformance, Root Cause, and Corrective Action Administer Nonconformance Material Reports (NCMRs/NCRs), support material-review and disposition activities, and coordinate assigned temporary deviations or controlled exceptions when authorized. Support root-cause investigations and corrective actions under the guidance of the Quality Manager, independently leading appropriately scoped investigations using methods such as 5 Whys, Fishbone (Ishikawa), and DMAIC tools. Prepare, coordinate, and follow up on Corrective Action Reports (CARs), Supplier Corrective Action Requests (SCARs), and other corrective or preventive actions. Collect and evaluate objective evidence to support corrective-action effectiveness verification and confirm that assigned actions address the identified root cause. Investigate manufacturing defects, assembly failures, customer complaints, field failures, returns, supplier escapes, and containment issues. Identify design-related or process-related contributors to quality issues and work with Engineering and Operations to reduce scrap, rework, escapes, and recurrence. Quality Management System and Audit Support Support ongoing compliance with AS9100D, ISO 9001, ISO 14001, customer-specific requirements, and applicable regulatory requirements. Prepare for and participate in internal audits, registrar audits, customer audits, supplier assessments, and TUV or UL facility audits, as applicable; support audit follow-up and closure of assigned findings. Support the process approach, risk-based thinking, document control, configuration management, product traceability, product safety, counterfeit-parts prevention, and Foreign Object Debris (FOD) prevention. Assist with creating, updating, and reviewing quality procedures, work instructions, inspection instructions, the Quality Manual, the Procedure Manual, and controlled quality records; provide training on assigned processes and documents. Maintain assigned portions of the Master Documentation Register and support document-control activities to ensure quality documents are current, approved, and properly controlled. Review purchase orders, customer quality clauses, specifications, and contract requirements to confirm quality obligations are identified and implemented. Support the calibration system for inspection, measuring, and test equipment, including record maintenance, recall coordination, and follow-up on overdue or out-of-tolerance equipment. Supplier Quality Work with suppliers and Supply Chain to resolve assigned quality issues and support supplier selection, approval, development, and ongoing performance monitoring. Support supplier audits, remote assessments, receiving-inspection planning, and supplier risk evaluations; participate in onsite supplier activities as experience and business needs require. Review supplier FAIRs and supporting objective evidence for compliance with AS9102 and customer requirements. Coordinate assigned supplier escapes, containment activities, corrective actions, and improvement actions, escalating significant risks or recurring issues to the Quality Manager. Maintain and analyze supplier scorecards and key performance indicators, including On-Time Delivery (OTD), Parts Per Million (PPM), Cost of Poor Quality (COPQ), corrective-action responsiveness, and other risk or performance measures. Support maintenance of the Approved Vendor List and communicate supplier-quality performance to Supply Chain and cross-functional stakeholders. Quality Metrics and Continuous Improvement Analyze assigned quality data and communicate trends, risks, and improvement opportunities using quality metrics and objective evidence. Track and report CORE process KPIs, Quality Objectives, FPY, nonconformance trends, supplier performance, corrective-action aging, and other departmental measures. Apply foundational quality-engineering methods such as risk assessment, sampling plans, basic Statistical Process Control (SPC), and data trending; participate in FMEA, process-capability (Cp/Cpk), and Gage Repeatability and Reproducibility (GR&R) activities with guidance as appropriate. Participate in Lean, Six Sigma, and other continuous-improvement projects and lead appropriately scoped improvement activities that enhance product quality, process capability, cost, delivery, or customer satisfaction. Use Microsoft Excel, ERP/MRP systems, quality-management software, and other business tools to analyze data, maintain records, and communicate results. Qualifications: Bachelor's degree in Engineering, Manufacturing, Industrial Technology, Quality, or a related technical field; an equivalent combination of education, technical training, and relevant experience may be considered. Three to five years of relevant quality, inspection, manufacturing-engineering, supplier-quality, or quality-engineering experience in a manufacturing environment, including at least one year supporting an AS9100 and/or ISO 9001 certified quality management system. Practical working knowledge of AS9100D and/or ISO 9001 requirements, including control of nonconforming products, document control, process controls, customer requirements, and risk-based thinking. Experience preparing, performing, or reviewing First Article Inspections and FAIR documentation; ability to read engineering drawings and apply basic GD&T concepts in accordance with ASME Y14.5. Familiarity with acceptance sampling principles such as ANSI/ASQ Z1.4 is preferred. Experience with root-cause analysis, nonconformance processing, corrective-action follow-up, quality metrics, and cross-functional problem solving; exposure to supplier quality is required, with direct supplier corrective-action experience preferred. Hands-on proficiency with common precision inspection tools and the ability to determine appropriate inspection methods. Working knowledge of electro-mechanical manufacturing and experience with several relevant processes, such as machining, sheet metal fabrication, plating or coatings, chemical conversion coatings, assembly, soldering, conformal coating, PCB/PCBA fabrication, electronics, special processes, or ESD controls. Proficiency with Microsoft Excel and Microsoft Office, with experience using ERP/MRP systems and quality-management, document-control, or inspection software. Strong written and verbal communication skills, attention to detail, sound judgment, and the ability to manage multiple priorities independently. Preferred Qualifications and Certifications Aerospace, defense, rugged electronics, medical-device, or other highly regulated manufacturing experience. ASQ Certified Quality Improvement Associate (CQIA), Certified Quality Technician (CQT), Certified Quality Engineer (CQE), or equivalent certification; certification in progress is also valued. AS9100 or ISO 9001 internal-auditor training, audit-participation experience, or interest in completing formal auditor training. Lean Six Sigma Yellow Belt or Green Belt, with practical exposure to DMAIC or structured continuous improvement. Formal GD&T training or certification. Exposure to customer-specific aerospace or defense requirements and quality clauses. Competencies: Clear Communication Clear and effective written and verbal communication skills with the ability to deliver the appropriate level of detail. Develop Relationships Has the ability to develop relationships with co-workers and to contribute to group solutions. Good Judgement Exercise good business judgment and makes good decisions and notifies management of issues and concerns. Positive Attitude Positive attitude with ability to work independently as well as collaboratively across all departments within the OSS Company. Budget Works with the company's budgetary guidelines while minimizing expenses and maximizing cost efficiency. Company Goals Understands Company and department goals and objectives and how to contribute. Physical Demands: This position operates in both office and manufacturing environments. The employee is frequently required to sit, stand, walk, communicate, use a computer, and use hands to handle inspection equipment and product. The employee may occasionally lift, push, or carry items up to 25 pounds and may assist with heavier items using appropriate equipment or team-lift practices. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
CNC Machinist III Full Time + Benefits (Medical, Dental, Vision, 401k with Company Match, PTO) Job Type: Onsite Shift: 1st Hourly Range: $32.00 - $39.00, DOE Location: Poway, CA Fralock is an engineered solutions provider of specialty components and subassemblies using advanced materials for high reliability, severe environment, and technically challenging applications. We develop and manufacture custom integrated solutions. Established in 1967, we are a critical solutions provider to Fortune 500 corporations, government, and targeted OEMs in a variety of industries including Semiconductor Equipment Manufacturing, Medical and Life Science, Aerospace and Defense, Industrial, Electronics, and Energy. Fralock is headquartered in Valencia, CA with manufacturing locations located throughout Northern and Southern California. VISION To be recognized by our customers as a leading solutions provider of proprietary engineered advanced materials for high reliability, severe environment, and technically challenging applications. MISSION To create value, profitably grow, and share our success with all stakeholders. CULTURE Respect – We treat others the way they want to be treated. Integrity – We practice a high standard of ethics in our business dealings with customers, suppliers, and employees. Responsiveness – We have a sense of urgency in responding to internal and external requests and work proactively to solve problems. Excellence/Competence – We empower our people to continuously improve and execute high quality work. Teamwork – We work together to achieve Fralock business objectives by communicating at a high level, by listening and having clarity in our expectations of one another. Individual Accountability and Personal Responsibility – We do what we have committed to do when we committed to doing it. Continuous Improvement across all segments of the company This position requires access to information controlled under the International Traffic in Arms Regulations (ITAR) or the Export Administration Regulations (EAR), the successful candidate must be a "U.S. person" as defined in the ITAR and EAR (which generally means (i) be a citizen or national of the United States; or (ii) be a lawful permanent resident of the United States; or (iii) have been admitted to the United States as a refugee, or have been granted asylum, as specified under applicable law. Job Summary Produces machined parts by setting up, programming as necessary and operating either a computer numerical control (CNC) machine, surface grinder, manual machine or other piece(s) of equipment; maintaining quality and safety standards; keeping records; maintaining equipment and supplies. This position reports to the Machine Shop Supervisor Key Responsibilities Inspect machinery to ensure the equipment is in good working order before start-up. Conduct all required setup, adjusting off-sets to close-tolerance specifications. Interpret and execute written instructions from process travelers, routers and work instructions. Perform in-process inspection of product to ensure specifications and quality requirements are met. Perform routine machine maintenance as required. Follow safety protocol. Report any safety or maintenance concerns to supervisor and/or management immediately. Keep all work areas clean and organized. Hold self to a high standard of quality and workmanship. Required Skills High school diploma or equivalent. 7+ years’ operating either CNC machines, manual machines, Blanchard machines or surface grinders, is preferred. Set-up machines, adjust programs, as necessary and operate machines independently. Ability to trouble shoot machinery and make small repairs. Interpret blueprints, technical drawings and diagrammed instructions. Use metrology hand-tools such as micrometers, calipers and dial-indicators for product inspection. Solid math skills, including measuring and keeping count records. Commitment to safety. Attention to detail. Standing, bending, lifting to 30 lbs. regularly for up to 8 hours/shift. Good verbal and written communication skills. Ability to work independently and as part of a team in a fast-paced environment with minimum supervision or direction. Experience Requirements Preferred 7+ years’ experience as a machinist or other relevant role (may be waived based on prior work experience). Education Requirements High School Diploma or equivalent. All offers of employment at Fralock are contingent upon clear results of a background check. Background checks may include some or all the following depending on job title and responsibilities: Social Security Verification Prior Employment Verification Criminal History Personal and Professional References Motor Vehicle Records Credit History Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of a position. Fralock provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
About the Job Set up welding machines based on the job at hand or using a Welding Procedure Specification. Read and interpret blueprints and/or drawings to determine the specific welding requirements. Flux Core, Stick and MIG weld steel and stainless steel components based on the specifications of the blueprints and/or drawings. Ensure work is done safely and meets quality standards. Follow, create and help maintain Welding Procedure Specifications. Operate machinery used in the production process, or assist machine operators. * Assemble items as instructed by floor supervisor. * Keep work areas clean and organized and take proper care of all equipment and facilities. * Follow all company rules and policies. * Provide a great level of attention to detail and focus on the given task. * Follow all safety rules and quality standards. * Work with team members to maximize productivity and efficiency. * Prepare product for shipment. * Lift raw materials, final products, and items packed for shipment, manually (up to 60 pounds), or using a hoist. * Uphold all OSHA standards applicable to the responsibilities above. Knowledge And Skill Requirements * High school diploma or equivalent * Experience With Steel, And/or Stainless Steel Required * Experience with Flux Core, MIG and Stick welding highly preferred. * Ability to lift heavy items up to 60 pounds consistently required. * Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods. * Ability to identify and measure material. * Ability to produce quality products consistently. * Ability to follow instructions given both verbally and in written form. * Willingness to learn and work to the best of his/her abilities as well as dependable work ethic. * Knowledge of machines and tools, including their designs and uses. * Ability to read blueprints, drawings, calipers, tape measures and angle gauges. * Ability to read and interpret documents furnished in written, oral, diagram or schedule form such as safety rules, operating and maintenance instructions, quality manuals and procedure manuals. * Familiarity with the metric system. * Ability to perform simple shop math, convert decimals to factional equivalents and fractions to decimal equivalents. * Must be reliable with a strong work ethic. * Ability to stand continuously for long periods of time. * Willing to work 40+ hours a week and weekend work from time to time. * Ability to travel to field jobs as well as overnight travel with team may be required. McKenna Boiler Works, Inc. is a 100 year old rapidly growing forward thinking turnkey solution provider for customers with steam or hot water needs. We have a great team of individuals that bring a variety of backgrounds to our manufacturing, service, mechanical and rental businesses. We are looking for top tier talent to help lead this company in achieving it's goals. Job Type: Full-time Pay: $20.00 - $30.00 per hour Benefits: * 401(k) * 401(k) matching * Dental insurance * Health insurance * Life insurance * Paid time off * Vision insurance Experience: * Welding: 2 years (Preferred) Language: * English (Preferred) * Spanish (Preferred) Work Location: In person
Job Title: - Production Technician I Pay Rate: $18-20/hr Status: Full-time Location: Carlsbad, California *ABOUT THE COMPANY* Located in Carlsbad, California, evanhealy is a leading and much-loved national organic skin care brand featured in leading natural markets such as Whole Foods Market. We’re looking for passionate individuals to join us in creating a regenerative future. We partner with tribal villages, women’s co-operatives, and family farms. Ancient traditions and their rituals shape our product ideas. It’s an inspiring and collaborative place to work, learn and grow. *POSITION SUMMARY* Production team members must be hard-working and have a focus on quality control, deadlines, sanitation, safety, and customer satisfaction. They must be self-starters, detailed-oriented, and able to work well with employees at all levels in the company. The primary responsibilities include, but are not limited to, inventory control, ensuring that each production phase (prepping, filling, labeling, and packaging) is completed and free of errors. *ESSENTIAL DUTIES & RESPONSIBILITIES* * Ensure each step of the production phase (prepping, filling, labeling, and packaging) is completed and free of errors * Complete production reports with 100% accuracy * Ensure proper use, setup and cleanliness of machines, equipment, and tools * Ensure that assigned tasks are complete and produced within established time limits * Accurately pick website and store orders * Accurately package orders and prepare for shipping and processing * Ability to learn and become knowledgeable about our skin care products * Must be able to regularly lift and/or move up to 40 pounds * *Proficient in English language — reading, writing + oral skills* * 1 + years of production, assembly or machine experience a plus * Knowledge of skin care products a plus *REQUIREMENTS* * Must have a minimum of 1 year recent production experience · *PHYSICAL REQUIREMENTS: *The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands; reach with hands and arms; stoop; talk and hear. Must be able to lift and carry up to 40 pounds. *BENEFITS PROGRAM* · Monday morning breakfast at an all-hands meeting (most Mondays) · Monthly company lunch · One free product each month · Employee discount program · Health insurance (60% paid by employer for employee only) Job Type: Full-time Pay: $18.00 - $20.00 per hour Benefits: * Health insurance * Paid time off Work Location: In person
The primary responsibility of the Quality Assurance Specialist II includes supporting ATEC’s quality system in compliance with ISO 13485, 21CFR820 and MDSAP. This position will ensure that auditing activities to maintain compliance, and support Document Control and Compliance Departments. This role supports the development and operation of the Quality Management System (QMS) at Alphatec Spine. This position also supports compliance to applicable domestic and international regulatory medical device regulations such as Part 820, 1271, MDD 93/42/EEC, ISO 13485:2003, Australian Therapeutic Goods (TGA), Japan (MHLW/PMDA). Essential Duties and Responsibilities Assist in the establish of systems to assure compliance with domestic (21CFR820) and international regulations (Australia: Australian Therapeutic Goods Administration, Japan: MHLW/PMDA Assist in implementation of changes for QMS procedures and policies to ensure compliance to ISO 13485 and specific country requirements. Partners with appropriate stakeholders to define, recommend and implement QMS process improvements. Plans and coordinates quality/compliance activities, identify roadblocks, and strategizes on various compliance paths for new products. Review documents to ensure regulatory compliance Designs, implements and maintains the quality systems ensuring compliance requirements Supports internal QMS audits as needed for compliance. Assists with Health Hazard Evaluations (HHE) with cross functional team members. Facilitates CAPAs as needed to ensure compliance along with timeliness of completion. Supports development of key QMS metrics. Provides analysis and reporting for Monthly Trend and Management Review Meetings. Assist the complaint handling system in accordance with domestic and international regulatory requirements, as needed. Performs other duties as assigned or required. Requirements The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Experience with quality system elements pertaining to medical devices and QMSR, QSR, cGMP and ISO 13485 and MDSAP familiarity is preferred. Ability to work independently, but equally in a team environment Strong written and very communication skills and attention to detail Self-starting, detailed oriented, quick learner, creative and analytical Capable of understanding and analyzing complex engineering problems Demonstrated leadership, and ability to solve problems and communicate issues Understanding of documentation system and management Experience in an FDA regulated environment desirable Microsoft Office knowledge, including Word and Excel, is a strong preference. Experience with SAP or Oracle Cloud system is a plus. Ability to communicate effectively with all levels of the organization Ability to prioritize multiple projects Ability to resolve conflicting interests and obtain cooperation Education and Experience Typically requires a Bachelor’s Degree and minimum of 2 years medical device experience For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable). ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws. Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $95,000 to $110,000 Full-Time Annual Salary Benefits Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k, IRA) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off (Vacation, Sick & Public Holidays) Family Leave (Maternity, Paternity) Short Term & Long Term Disability Free Food & Snacks Stock Option Plan
CNC Machinist III Full Time + Benefits (Medical, Dental, Vision, 401k with Company Match, PTO) Job Type: Onsite Shift: 1st Hourly Range: $32.00 - $39.00, DOE Location: Poway, CA Fralock is an engineered solutions provider of specialty components and subassemblies using advanced materials for high reliability, severe environment, and technically challenging applications. We develop and manufacture custom integrated solutions. Established in 1967, we are a critical solutions provider to Fortune 500 corporations, government, and targeted OEMs in a variety of industries including Semiconductor Equipment Manufacturing, Medical and Life Science, Aerospace and Defense, Industrial, Electronics, and Energy. Fralock is headquartered in Valencia, CA with manufacturing locations located throughout Northern and Southern California. VISION To be recognized by our customers as a leading solutions provider of proprietary engineered advanced materials for high reliability, severe environment, and technically challenging applications. MISSION To create value, profitably grow, and share our success with all stakeholders. CULTURE Respect – We treat others the way they want to be treated. Integrity – We practice a high standard of ethics in our business dealings with customers, suppliers, and employees. Responsiveness – We have a sense of urgency in responding to internal and external requests and work proactively to solve problems. Excellence/Competence – We empower our people to continuously improve and execute high quality work. Teamwork – We work together to achieve Fralock business objectives by communicating at a high level, by listening and having clarity in our expectations of one another. Individual Accountability and Personal Responsibility – We do what we have committed to do when we committed to doing it. Continuous Improvement across all segments of the company This position requires access to information controlled under the International Traffic in Arms Regulations (ITAR) or the Export Administration Regulations (EAR), the successful candidate must be a "U.S. person" as defined in the ITAR and EAR (which generally means (i) be a citizen or national of the United States; or (ii) be a lawful permanent resident of the United States; or (iii) have been admitted to the United States as a refugee, or have been granted asylum, as specified under applicable law. Job Summary Produces machined parts by setting up, programming as necessary and operating either a computer numerical control (CNC) machine, surface grinder, manual machine or other piece(s) of equipment; maintaining quality and safety standards; keeping records; maintaining equipment and supplies. This position reports to the Machine Shop Supervisor Key Responsibilities Inspect machinery to ensure the equipment is in good working order before start-up. Conduct all required setup, adjusting off-sets to close-tolerance specifications. Interpret and execute written instructions from process travelers, routers and work instructions. Perform in-process inspection of product to ensure specifications and quality requirements are met. Perform routine machine maintenance as required. Follow safety protocol. Report any safety or maintenance concerns to supervisor and/or management immediately. Keep all work areas clean and organized. Hold self to a high standard of quality and workmanship. Required Skills High school diploma or equivalent. 7+ years’ operating either CNC machines, manual machines, Blanchard machines or surface grinders, is preferred. Set-up machines, adjust programs, as necessary and operate machines independently. Ability to trouble shoot machinery and make small repairs. Interpret blueprints, technical drawings and diagrammed instructions. Use metrology hand-tools such as micrometers, calipers and dial-indicators for product inspection. Solid math skills, including measuring and keeping count records. Commitment to safety. Attention to detail. Standing, bending, lifting to 30 lbs. regularly for up to 8 hours/shift. Good verbal and written communication skills. Ability to work independently and as part of a team in a fast-paced environment with minimum supervision or direction. Experience Requirements Preferred 7+ years’ experience as a machinist or other relevant role (may be waived based on prior work experience). Education Requirements High School Diploma or equivalent. All offers of employment at Fralock are contingent upon clear results of a background check. Background checks may include some or all the following depending on job title and responsibilities: Social Security Verification Prior Employment Verification Criminal History Personal and Professional References Motor Vehicle Records Credit History Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of a position. Fralock provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Job Purpose: Our Testing Lab Technician will perform a variety of laboratory procedures of technical nature ensuring compliance with company, customer, industry and regulatory requirements. This position supports the business and our customers by performing standardized tests, producing and documenting reliable results, preparing technical reports and maintaining safe laboratory environment. Job Responsibilities: Conduct testing such as ISTA distribution and cold chain tests. Document test data and test reports using Good Documentation Practices. Interpret and execute industry test standards from organizations such as ISTA, ASTM, and customer protocols. Safely operate test lab equipment. Work on multiple projects simultaneously. Maintain responsive communication with sales reps and customers regarding test status, updates, and results. Work collaboratively with internal departments. Perform other duties as assigned. Additional Responsibilities & Qualifications: Minimum 1 year industry or testing lab experience or packaging related degree. Have a basic understanding of packaging principles and types of corrugated boxes. ISTA Packaging Dynamics Professional certification preferred. Ability to work independently, successfully manage accounts, work under pressure, and adapt to changes in the work environment is essential. CAD software experience (ArtiosCAD, Solidworks) preferred. Work Experience: 1-3 years of related job experience. Ability to work in a team environment. Ability to work quickly and efficiently. Excellent verbal, written, people, and diplomacy skills are required. Must be highly motivated, flexible and deadline driven. Proficient with Microsoft Office Suite. Strong customer service skills (friendly, courteous and helpful). Strong planning and organization skills are required. Strong problem-solving and attention to detail skills are required. Education: Bachelor's Degree Preferred Working Conditions and Physical Requirements: Ability to lift and move up to 50 pounds. Frequent standing, walking, bending, and reaching. Ability to handle packaging samples and testing equipment safely. Ability to work in both laboratory and warehouse environments. What We Offer Engaging and inclusive culture with employee-led Employee Resource Groups, Veritiv Cultural Alliance, recognition platform, etc. Extensive training opportunities, professional development programs, career pathing, and mentorship opportunities. Collaborative atmosphere with our customers and suppliers to create healthier, safer and more sustainable communities through our responsible operations and innovative solutions. Healthcare benefits (including medical, dental, vision, and health savings account), life, AD&D, and disability insurance, 401k, paid time off, tuition reimbursement, employee assistance program, and other fringe benefits. About Veritiv Together with its subsidiaries, Veritiv is the leading full-service provider of packaging solutions. Veritiv also provides JanSan, hygiene, print and publishing products and services. Veritiv serves customers in a wide range of industries, through team members around the world helping shape the success of its customers. For more information, visit www.veritiv.com and connect with the Company on LinkedIn. Veritiv is an Equal Opportunity/Affirmative Action employer. EEO Policy US | EEO Policy Mexico This description does not attempt to define the job's essential functions as defined by applicable disabilities law.
Quality Engineer Department: Quality Reports To: Quality Manager Salary Range: $80-$95,000 depending on experience Why Join Us? Gain exposure to new technologies, automated inspection systems, and cross-functional leadership opportunities Competitive pay, PTO, and benefits Strong team culture focused on quality and improvement About Us ARCH Global Precision manufactures high-precision components and engineered solutions for customers in demanding industries. Through advanced manufacturing capabilities, technical expertise, and a strong commitment to quality, we help our customers bring innovative products to market with confidence. About the Role We are seeking an experienced Quality Engineer to join our Quality team. This position plays a critical role in ensuring customer satisfaction, reducing internal scrap, driving continuous improvement initiatives, and supporting product and process validations. The ideal candidate is detail-oriented, analytical, and thrives in a fast-paced manufacturing environment while collaborating effectively with cross-functional teams. Key Responsibilities As a Quality Engineer, you will: Develop and maintain quality plans, inspection plans, control plans, work instructions, and PFMEAs. Support new product introductions, product revisions, and process development activities. Participate in product qualifications, validations, and change control processes. Collaborate with Engineering to review drawings and ensure customer requirements are clearly defined and understood. Conduct measurement system analyses including GR&R studies and establish effective inspection methods. Lead or support Material Review Board (MRB) activities and nonconformance investigations. Manage customer complaints, CAPAs, NCMRs, and corrective action activities. Utilize quality tools such as Root Cause Analysis, FMEA, Risk Analysis, SPC, and 8D problem-solving methodologies. Perform internal audits and support external audits as required. Analyze process data and conduct process capability studies to drive continuous improvement. Train employees on quality requirements, inspection methods, and metrology practices. Support equipment validations and qualification activities in partnership with Maintenance, IT, and Operations teams. Drive initiatives to improve manufacturing quality, efficiency, and customer satisfaction. Required Qualifications Bachelor's degree in Manufacturing Engineering, Quality Engineering, or a related technical discipline, or an equivalent combination of education and experience. Minimum of 3 years of quality engineering experience in a manufacturing environment. Strong knowledge of quality systems, methodologies, and problem-solving tools. Experience with CAPA programs, process capability studies, GR&R, PFMEA, and SPC. Knowledge of ISO standards, preferably ISO 13485, and FDA regulations including 21 CFR Part 820. Strong written and verbal communication skills. Proficiency in Microsoft Office applications including Word, Excel, Outlook, and PowerPoint. Ability to work effectively in a cross-functional team environment. Preferred Qualifications ASQ Certification (CQE, CSQE, Six Sigma Black Belt, Lean, or equivalent). Strong GD&T knowledge and experience. Experience with Minitab. Experience using automated inspection equipment such as CMMs, Keyence, Vertex, or similar systems. Experience developing manufacturing quality plans and driving process optimization projects. What We're Looking For High energy and self-motivation. Strong attention to detail and accountability. Excellent analytical and problem-solving abilities. Effective interpersonal and communication skills. Ability to manage multiple priorities in a fast-paced environment. Commitment to continuous improvement and operational excellence. Physical Requirements Ability to sit, stand, walk, talk, and hear frequently throughout the workday. Regular computer use. Ability to lift up to 20 pounds occasionally. Equal Opportunity Employer Additional Notes ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
Duties / Responsibilities: Manager - Quality Engineering provides direct management and technical support to the Quality Engineers supporting the REVA Medical business needs, including compliance, risk remediation, new product development, and cost reduction efforts linked to operational effectiveness Provide support/ mentoring/ coaching of QEs for application of technical principles, theories, concepts and quality, tools and systems; develop personnel, including dedicated succession planning and contingency management focused on win-win situations The position shall provide quality engineering leadership, oversight, and direction in problem-solving and team-building capabilities. The position shall support new product development and product maintenance through the application of Quality engineering skills for medical devices, assuring that all REVA products are designed utilizing systems which comply with applicable quality standards, industry and government standards/regulations and ultimately conform to customer expectations for safety and effectiveness. Develop and ensure the execution of process/equipment IQ/OQ/PQ protocols and reports. Conduct test method qualifications and validations. Develop gauge reliability and repeatability studies for test and production-related equipment. Develop equipment calibration procedures. Develop sampling plans for incoming materials and in-process and finished product testing based on appropriate statistical methods. Responsible for product-related investigations and corrective actions. Maintain a working relationship with suppliers to ensure resolution of supplier-critical issues and investigations. This may include supplier visits to technically assist in the resolution of issues and investigations. Ensure that all corrective/preventive measures meet acceptable reliability standards, and that documentation is compliant with requirements. Assure that the policies, procedures, and systems are designed and implemented to develop products which conform to established Lead execution of Quality activities required to meet established Business Goals and quality metric targets for product platforms and/or processes. Develops technical solutions and program management to address complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity Product expert that ensures customer requirements are met Assumes a leadership role in continuous improvement and development of strategies to improve Quality As part of the quality organization, reviews and approves assigned controlled documents (e.g. work instructions, quality specifications, engineering specifications, procedures and validations protocols/reports). Establish and maintain a team structure that provides excellent customer service and enables optimal use of resources Provide required input for Management Review Provide the required Quality Engineering support and promote use of statistical tools in product design and development activities Lead Risk Management activities for products under design authority in compliance with ISO 14971 Provide feedback to prepare budget and adhere to approved departmental budget Participates in, and may provide leadership for multi-disciplinary projects Participate in customer product complaint analyses, evaluation and investigation. Perform investigational activities including evaluation of returned products and complaint trending analysis. In conjunction with product development, participates in the updating, maintaining, and approving of risk analysis/risk management documentation. Participates in internal/supplier audits and interact with external regulatory inspectors as subject matter expert. Participates in and manages special projects and other duties as assigned. Education and/or Experience Bachelor's degree in mechanical engineering, chemical engineering, biomedical engineering, and/or other engineering related degree Minimum of 5-7 years medical device experience or similarly regulated ISO or cGMP/GLP environment is required. Previous experience with catheters and/or medical devices is required. Interventional cardiology products experience is helpful. Experience in conducting complaint/CAPA investigations Proven record of validation and compliance of regulated products is required. E-beam sterilization validation and software validation experience is preferred. Experience with regulatory requirements and guidance for component and product testing including ASTM, ISO and ICH. Required Knowledge/Skills Strong statistical background and practical application of statistical techniques (Six Sigma, DOE, etc) Demonstrated problem solving and root cause analysis skills using risk-based approach ASQ certification (QE, and/or Auditor) preferred Strong attention to detail and accuracy Ability to train others, work independently or in team setting required. Effective presentation/communication skills, prioritization and resource management skills. Physical Demands/Working Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit or stand for prolonged periods of time, frequently in front of a computer. Must be able to travel approximately ~15% of the time.
table.MiTabla { max-width: 1020px;!important Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Manufacturing Technician I Monday – Friday 6:30AM – 3:00PM The Manufacturing Technician I performs fundamental tasks within a GMP environment in support of more complex manufacturing operations. The tasks include, but are not limited to, cleaning and maintaining the work place so that it meets the standards for controlling bioburden levels; cleaning operating equipment per applicable procedures so that it meets the standards established to prevent product contamination and maintaining records/logs neatly and accurately and in accordance with current standard procedures. The technician performs job tasks in a safe manner while following specific department safety rules. PRIMARY RESPONSIBILITIES: Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals. Detailed cleaning of equipment/facilities to MSP/cGMP standards. Complete technical training profile as required. Strict adherence to Dept. Safety Rules. Bulk processing and filtration involving monitoring processing parameters (i.e. pH, weights, separation, assay results). Perform real-time documentation during the production run. ADDITIONAL RESPONSIBILITIES: English fluency both verbal and written. Basic math skills with proficiency in metric system. Accurate documentation skills are a must. Basic computer skills. Mechanical aptitude. Must be available to work any shift, including weekends. Ability to work well with others in a team environment is essential. Self-starter with the ability to work independently and use good judgment. Must be able to handle multiple priorities. Must be proactive, results oriented, and have strong attention to detail EDUCATION: High school diploma or GED required. Associates Degree or Bachelor’s degree preferred. Manufacturing, or experience in pharmaceuticals/biologics processing in a GMP environment is preferred. EXPERIENCE: 1-2 years’ experience in a manufacturing environment preferred. SKILLS & ABILITIES: Accurate documentation and attention to detail oriented. Usage of a 10-key calculator. OCCUPATIONAL DEMANDS: Ability to lift/push 50 lbs. All work is performed in a clean room (sanitized) manufacturing environment and must gown up. Must be able to work in a cold environment, job requires bending or standing for prolonged periods. This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned. #BiomatUSA The estimated pay scale for Manufacturing Technician I role based in California, is $18.70-$28.50 per hour. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. California Personnel Privacy Policy and Notice at Collection Location: NORTH AMERICA : USA : CA-Vista: USVISTA2 - Vista CA-980 Park Center Drive-AC Learn more about Grifols
Hydranautics is a part of the Nitto Group of companies and a global leader in the field of integrated membrane solutions which includes reverse osmosis, nanofiltration, ultrafiltration and microfiltration for water, wastewater and process treatment and applications. Currently used on seven continents throughout the world for diverse applications such as seawater desalination, industrial high-purity water, surface water treatment, wastewater treatment and specialty process applications. Here at Hydranautics, we believe that diversity is key to our competitive advantage. All qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, ancestry, sex, sexual orientation, age, disability, marital status, domestic partner status or medical condition. We are proud to be a Drug-free, E-Verify and EEO employer. We are proud to offer a generous compensation and robust benefits package to include medical, dental, vision, life insurance plans, F.S.A. and H.S.A plans, Retirement plans (401k and ROTH), (12) Paid company holidays, generous PTO, tuition reimbursement and career development, Employee Assistance Plan, and more. This is an onsite position in our Oceanside, CA facility. We presently have the following Production Operator II and III positions available for 2nd and 3rd shifts. JOB SUMMARY: Under the general supervision of the Engineering Director, the Senior Mechanical and Automation Engineer is responsible for designing, developing, and implementing mechanical and automated solutions that transform labor-intensive, heavy-handling membrane manufacturing operations into safe, efficient, and scalable engineered processes. This role requires multidisciplinary expertise spanning mechanical design, electrical systems, and PLC/automation programming, with a strong automation mindset and advanced proficiency in risk management tools including Process FMEA (PFMEA), Machine FMEA, Assembly FMEA, Poka Yoke error-proofing, Risk Priority Number (RPN) management, and Control Plan governance. The incumbent operates in a challenging manufacturing environment characterized by unstructured legacy processes, outdated documentation, heavy manual handling operations, and budget and safety constraints that demand creative engineering solutions. ESSENTIAL DUTIES and/or RESPONSIBILITIES: Design, develop, and commission mechanical and automated equipment to eliminate manual heavy-handling operations in membrane manufacturing; apply DFM and DFS principles to produce safe, cost-effective, and maintainable solutions within defined capital budget constraints. Lead and facilitate Process FMEA (PFMEA), Machine FMEA, and Assembly FMEA sessions across new and existing manufacturing equipment and processes; assign Severity, Occurrence, and Detection ratings; calculate and manage Risk Priority Numbers (RPN); and drive corrective actions to target RPN thresholds prior to production release. Apply Poka Yoke (mistake-proofing) principles to equipment and process designs including fixture-based error-proofing, sensor interlocks, visual management systems, and assembly verification mechanisms to eliminate defect escape and ensure consistent product quality in membrane production operations. Develop, maintain, and govern Control Plans aligned with PFMEA outputs; define process control parameters, inspection frequency, measurement methods, and reaction plans; ensure Control Plans are sustained and updated as processes evolve. Program, configure, and troubleshoot PLC-based automation systems (Allen Bradley, Siemens, or equivalent), HMI interfaces, servo/stepper drives, pneumatic controls, and vision inspection systems to support new equipment commissioning and ongoing production reliability. Assess, document, and formalize legacy and underdeveloped process flows, SOPs, work instructions, and engineering standards; establish a structured documentation and engineering change control system to support process repeatability, operator training, and audit readiness. Conduct risk assessments including Job Hazard Analysis (JHA) and machine safety reviews for all new and modified equipment; ensure compliance with OSHA 29 CFR 1910, NFPA 70, ANSI B11 machine guarding standards, and Hydranautics EHS policies; integrate safety engineering controls (guarding, interlocks, E-stop systems) into all designs. Lead small cross-functional project teams (engineers, technicians, contractors) through full project lifecycle: scoping, design review, procurement, installation, qualification, and production handoff; manage project schedule and budget with regular status reporting to Engineering Director. Develop capital project business cases including ROI analysis, cost-benefit justification, and phased implementation plans for management approval; manage vendor quotes, contractor oversight, and procurement activities within approved budget frameworks. Partner with production, quality, maintenance, and EHS teams to resolve equipment reliability issues using structured root cause analysis methodologies (5-Why, Fishbone, DMAIC); implement and verify sustainable corrective and preventive actions. Other duties as assigned. SUPERVISORY RESPONSIBILITES: This position leads small project teams of 2–5 engineers, technicians, or contractors on a project basis. No direct supervisory authority over permanent headcount. MINIMUM EDUCATION and/or EXPERIENCE: Bachelor's degree in Mechanical Engineering, Mechatronics, Electrical Engineering, or a closely related engineering discipline and 8–12 years' experience in a manufacturing engineering or automation engineering role, or equivalent combination of education and experience. KNOWLEDGE, SKILLS and/or ABILITIES: Expert-level mechanical design proficiency using 3D CAD software (SolidWorks, AutoCAD, or equivalent); ability to produce and manage engineering drawings, GD&T specifications, tolerancing analysis, and BOM documentation for complex mechanical assemblies and automated systems. Hands-on electrical and controls engineering competency: panel wiring, PLC programming (Allen Bradley/Rockwell, Siemens, or equivalent), HMI configuration, servo and stepper drive commissioning, pneumatic system design, and sensor/vision system integration. Advanced mastery of FMEA methodologies: ability to independently lead and facilitate Process FMEA (PFMEA), Machine FMEA, and Assembly FMEA sessions; assign Severity, Occurrence, and Detection ratings; calculate RPN scores; prioritize and drive risk mitigation actions to defined target thresholds before production release. Expert application of Poka Yoke (mistake-proofing) design principles: fixture-based error-proofing, sensor-based detection and rejection interlocks, visual management and color-coding systems, and assembly verification mechanisms to prevent defect escape in membrane manufacturing operations. Proficiency in Control Plan development and ongoing governance: linking PFMEA outputs to process control parameters, measurement system requirements, inspection frequency, reaction plans, and SPC monitoring triggers; ability to train operators and technicians on Control Plan requirements. Strong working knowledge of Lean Manufacturing and Six Sigma tools including VSM, DMAIC, FMEA, 5S, SMED, and Kaizen facilitation; Six Sigma Green Belt certification or equivalent applied project experience required. Demonstrated ability to develop, formalize, and govern engineering documentation in legacy or underdeveloped environments: SOPs, work instructions, process flow diagrams, engineering change orders, and equipment qualification and validation records. Read and comprehend highly complex engineering specifications, regulatory standards, and technical documentation; write technical reports, engineering proposals, and capital justifications; effectively present recommendations to cross-functional stakeholders and management in one-on-one and group settings. Strong project management skills: ability to manage multiple concurrent engineering projects, vendor relationships, and contractor activities within approved budget and schedule; proficiency in MS Project or equivalent project management tools. Advanced Microsoft Office Suite skills (Word, Excel, PowerPoint, Outlook); working knowledge of ERP/MRP systems (JD Edwards or equivalent) for materials planning, requisition management, and project cost tracking. CERTIFICATES and/or LICENSES: Six Sigma Green Belt (required); Black Belt preferred. OSHA 30-Hour General Industry certification preferred. PLC Programming certification (Allen Bradley/Rockwell or Siemens equivalent) preferred. PHYSICAL DEMANDS and/or WORK ENVIRONMENT: (Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) Works in a manufacturing production floor environment with regular exposure to noise, chemical agents, moving automated equipment, and varying temperatures; appropriate PPE (safety glasses, gloves, steel-toed footwear, hearing protection) required in designated areas. Regularly required to stand, walk, and work on the production floor for extended periods during equipment installation, commissioning, troubleshooting, and operator training activities. Occasional lifting, pushing, or carrying of items up to 35 lbs during equipment setup, component handling, and inspection activities. Availability and willingness to travel to vendor sites, supplier facilities, or other Nitto Group locations domestically when required as part of equipment procurement, qualification, or business support activities. Must be able to work extended hours including evenings or weekends during critical equipment commissioning phases or production support events per the demands of the business.