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Responsibilities Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality. Assures conformance with regulations of the FDA and other international regulatory agencies and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance. Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system. Work with cross-functional teams to coordinate product changes. Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc. Provide corporate quality support, guidance and direction for bringing on-market product issues to closure and escalating to senior management for support as necessary. Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality. Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks. Ensure compliance, alignment and consistency with ICU Medical’s quality system. Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections. Work special projects as assigned. *Hybrid work from home is permissible. When not working from home, must report to San Clemente, CA office. *5-10% domestic and international travel required per year. EDUCATION AND EXPERIENCE REQUIREMENTS: Bachelor’s degree (or foreign equivalent) in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering, or closely related field plus Seven (7) years of experience in the job offered or a closely related occupation. SPECIAL REQUIREMENTS: Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be “quantified” by “time.” Required expertise/knowledge includes: Knowledge of the Medical Device Industry and experience in ISO and FDA QSR regulations, including ISO 13485 and ISO 14971; Knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System, including Design Controls, CAPA, Complaints, and Document Control; Experience in managing Design Control elements, Design History Files and Device Master Records; Experience in supporting 510K and Technical File submissions; Experience in creating Design V&V protocols and reports; Experiences in initiating and managing Risk Management documents (HA, DFMEA, PFMEA); Familiarity with international regulations including REACH and RoHS compliances; Experience in investigations, risk assessments and associated CAPA activities; Knowledge in Statistical Analysis Techniques; Experience with Quality compliance, audit and investigation. ICU Medical, Inc. is an equal opportunity employer. 40 hours per week / $140,774 - $161,000 per year To apply for ICU Medical’s Senior Engineer, Design Quality position please send resume to: [email protected] Must reference JOB CODE: CA0606PS
HME has been creating innovative products for the drive-thru and pro-audio industries since 1971. From the very beginning, we've known these solutions would never have happened without the customer-focused people who make up our company. HME has a team environment with a culture of collaboration, learning, and growth. With subsidiaries located in California, Missouri, Canada, UK, India, and China, companies around the world depend on HME for clear, reliable communication solutions. From setting the standard for drive-thru headsets and timer systems in the quick service restaurant (QSR) industry to developing professional audio equipment used in the Olympic Games, HME strives to create the newest, most innovative products on the market while providing quality care and attention to its customers. Come join our team! We are currently recruiting for an SMT Machine Operator I. In this role, you will performs SMT machine placement and assembly of surface mounted components on Printed Circuit Boards (PCB). This is a 1st shift position working 5:30am - 2:00pm What you will do in the position: Load, calibrate, and operate SMT machine Load SMT pick-and-place machine with components as outlined the documents provided Calibrate and align component pick-up locations Initiate Printed Circuit Board (PCB) assembly Report all assembly errors to the Lead and/or Supervisor Use the microscope to verify correct component placement and orientation Manually align components prior to reflow within approved guidelines Apply solder paste to PCBs using the MPM 100 or MPM 2500 printing equipment Bake populated PCBs using the reflow oven Perform post reflow inspection and touch-up Maintain general cleanliness of the SMT Production area and equipment Lead and/or Supervisor of all unresolved and/or potential problems which may affect the production schedule or quality of work What you will need to succeed in this position: Excellent communication and organizational skills Ability to read and interpret assembly drawings, documents, and aides as required Excellent eye-hand coordination The starting rate is $18.00. Our benefits package includes tuition reimbursement; 3 weeks paid vacation your first year, paid holidays, medical, vision, and dental coverage, pet insurance, life insurance, and 401K contributions. The work environment described here are representative of those that an employee would work within. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions. This job requires frequent contact outside the department or company and the noise level in the work environment is usually quiet to moderate with occasional loud noise. The employee occasionally works near moving mechanical parts, works in high, precarious places, is exposed to fumes and/or airborne particles, toxic or caustic chemicals, outdoor weather conditions, and is regularly at risk of electric shock. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities 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.
This is a possible temp-to-hire position at a growing company in the Carmel Mountain area. The main duty is to test the pumps by running fluid under different conditions. Then, working out issues and documenting. The position is somewhat routine in nature. Pay: $20.00 - $23.00 per hour Work Location: In person
HME has been creating innovative products for the drive-thru and pro-audio industries since 1971. From the very beginning, we've known these solutions would never have happened without the customer-focused people who make up our company. HME has a team environment with a culture of collaboration, learning, and growth. With subsidiaries located in California, Missouri, Canada, UK, India, and China, companies around the world depend on HME for clear, reliable communication solutions. From setting the standard for drive-thru headsets and timer systems in the quick service restaurant (QSR) industry to developing professional audio equipment used in the Olympic Games, HME strives to create the newest, most innovative products on the market while providing quality care and attention to its customers. Come join our team! Come write your chapter of the HME story. Are you good with your hands? Do assembly instructions make sense to you? Are you looking to start a new career and not just another job? HME is actively recruiting candidates with great Attitudes and Aptitude for a temporary (4 months) Assembler Tester I, 2nd shift. In this position, with training and under direct supervision, performs various electro-mechanical assembly, test and inspection procedures to ensure that production schedules and quality standards are met. May use automated test equipment, handheld tools, soldering iron, assembly drawings, bills of materials, schematics, written instructions, and/or other applicable documents. This is a 2nd shift position working 2:30 - 11:00pm Monday-Friday. What you will do in the position: Assembles, reworks, and/or reassembles product as specified on applicable documentation. Verifies accuracy of instruction documents (e.g. schematics, assembly drawings, bills of material). Checks work for accuracy, quality, and conformance to specifications. Uses a computer for data entry and inputs serial numbers into the mainframe. Packages parts into kits for shipping. Labels and packages product including manuals and accessories. Informs supervisor or lead of work-related problems. Record test data and results What you will need to succeed in this position: Up to 6 months electronics assembly experience Ability to perform basic assembly operations. Ability to read and interpret manufacturing drawings and assembly aides. Ability to complete assignments within specific time parameters under direct supervision. Good verbal, reading, writing, and comprehension skills. Basic computer skills. Good manual dexterity. Basic computer skills GED required The starting rate is $18.00/hr plus a 10% shift differential. This may vary depending on experience and other factors. The physical demands and work environment 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. The employee will occasionally lift and move up to 50 pounds with assistance. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities 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.
POSITION DESCRIPTION Job Title: Operations & Maintenance Technician I Reports To: Operations & Maintenance Manager Direct Reports: No Functional Unit: Operations FLSA Status: Non-Exempt Position Type: Full-Time Plant Location: Escondido, CA THE COMPANY Onward Energy is an independent power platform that owns and operates over 7 GW of utility-scale wind, solar and natural gas generation projects across the U.S. Our Vision is to reliably power a sustainable future. Our Mission is that as North America’s premier independent power generator, we will deliver renewable and reliable power to our customers, opportunities to our employees, sustainable returns to the families who invest in us, and a better world to the next generation. Corporate Offices in Denver, New York and Charlotte, we are where renewable meets reliable. See www.onwardenergy.com for more information. Goal Line is a 49.9-MW natural gas-fired combined cycle power plant located in Escondido, California. This facility is interconnected with the transmission system owned by San Diego Gas & Electric (SDG&E) within the California Independent System Operator (CAISO) market. Goal Line sells electricity generated as a Merchant Facility participating in the Resource Adequacy Market. THE CHALLENGE Journey-level position responsible for start, stop and monitoring of equipment including reading gauges, meters and recording activities in operating logs and records. Uses computers and monitoring equipment to measure, record and make adjustments within operating parameters. Performs a variety of plant maintenance tasks including diagnosis, maintenance and repair of mechanical and electrical equipment in a safe, efficient and economical manner. Performs overhaul maintenance and system improvement tasks. Incumbents assist in the development of operational procedures, operator training modules and provide input to plant betterment items to improve plant safety, reliability and efficiency. Ensures compliance with all local, State and Federal regulations and plant procedures. THE RESPONSIBILITIES Work periodically reviewed by others; work reflects solid performance of duties. Resolves most questions and problems and refers only the most complex issues to higher levels. Works under general supervision. Prioritize daily activities to complete tasks/projects assigned by others. Performs a variety of technical services/support duties that are semi-routine in nature. Routine and non-routine decisions with some latitude, but still subject to approval. With limited guidance, prioritizes and executes responsibilities effectively for a single trade, group of related tasks or functional areas. Errors have a small and possibly incremental impact on department or facility and discovered in succeeding operations where work is verified or reviewed. May assist with orienting and training employees in moderately complex areas. Assists on shift, qualified O&M Technicians in routine daily operations and maintenance troubleshooting and repair tasks. Responsible for all safety aspects of operating equipment. Conduct safety presentations. Complete all O&M Tech II training requirements within 24 months. Must be available for night, overtime, weekend, and holiday work as required. May be required to support job responsibilities as needed outside of scheduled work hours. Occasional travel may be required. Other duties as assigned. THE PROFILE TO SUCCEED High School Diploma, related military service or equivalent. Preferred Associates degree (AA) or equivalent from a two-year college, trade school certification or advanced education in mechanical, electrical, or instrumentation. Journey-level; generally, 5 years directly related experience including understanding of environmental and safety regulations, and previous experience working as a plant operator. Requires experience working with and around hazardous chemicals and waste materials. Requires previous experience using testing equipment & calibration appliances. Requires additional experience with machinery repair and control systems. Basic certifications/licensures. Strong verbal and written communication skills, interpersonal skills and possess the ability to learn. Strong mechanical aptitude and understanding of chemistry, physics, electricity and mathematics. Ability to exercise good judgment and make sound decisions. Excellent organizational skills with attention to detail, accuracy, and timeliness. Strong analytical and problem-solving skills. Ability to follow both verbal and written instructions. Ability to demonstrate basic computer knowledge of Word, Excel, Power Point and various other programs. Ability to interact and communicate well with individuals in all areas of the company and outside vendors. Valid U.S. Driver license with acceptable MVR history, if applicable. THE PHYSICAL REQUIREMENTS Must be able to accomplish physical requirements with or without reasonable accommodation. Adhere to large amounts of standing, walking, bending, squatting, and lifting. May be required to lift, carry, and move up to 50 lbs. Will use arms and hands to signal, grab, hold, turn, push, and pull objects, materials, controls and tools. Will occasionally work at heights, climb ladders, stairways, and work off platforms. Will use vision abilities to focus, see short and long distances, colors, depth perception and peripheral vision. Will be required to wear personal protective equipment (PPE) including but not limited to hard hat, safety glasses/goggles, ear plugs/muffs, masks/respirators, safety vests, gloves and steel-toe boots. Able to hear (at some dB limit of loss) in order to hear plant alarms, equipment condition, and to receive oral instructions. Able to see to determine plant operating conditions and to avoid safety hazards. THE TEAM The Onward Energy team is comprised of industry professionals who embrace our values of accountability, adaptability, collaboration, and excellence. At Onward Energy, we seek to find solutions rather than assign blame. THE WORK ENVIRONMENT Performing this job without full/focused attention may cause serious injury or even fatality. Work is generally performed inside the power plant but may work in all weather conditions ranging from warm/hot - cool/cold. Occasional rain. Noise levels will be moderate to high. Job site will contain light to heavy equipment vehicles, small to large equipment, materials, communication equipment and tools. People standing, walking, sitting, signaling and talking. Bells, whistles and alarms. THE TOTAL REWARDS Onward Energy total rewards philosophy is motivated by a key tenet of People First, and offers employees a comprehensive total rewards package which includes market competitive compensation, health, life insurance, and retirement savings benefits. If you require an accommodation for any part of the employment process due to a disability to [email protected]. EEO STATEMENT: Onward Energy is an Affirmative Action Employer, Females/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About the role: Primary focus is to build product by following processes and instructions to meet validation and build goals. Work Mode At Boston Scientific, we value collaboration and synergy. This role follows a onsite work model, requiring employees to be in our local office five days per week. Relocation Relocation assistance is not available for this position at this time. VISA Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time. Your responsibilities will include: Assemble, repair, inspect and/or test products following instructions. Ability to read and comprehend basic instructions and other work-related documents, written in English. Work with engineers on process modifications and suggest process improvement opportunities. Set up and operate a variety of manufacturing machines or equipment following written instructions in English. Clean tools and equipment per instructions. Record information on approved documents. Dispose hazardous waste material on corresponding hazardous waste areas. Resolve problems and make routine recommendations. Train other employees when necessary. Maintain all certifications required to remain in compliance. Work overtime as required. Sit and/or stand for extended periods of time as needed. Required qualifications: High School Diploma or equivalent 2 years to less than 5 years of work experience in manufacturing and/or assembly Ability to use and adjust a microscope Ability to work with small parts for an extended period of time This position requires proficiency in communication and understanding of English, including reading work instructions to consistently build defect free medical products. Preferred qualifications: Previous medical device experience preferred, but not required. Experience with soldering, hand tools and power tools/drills. Experience working with catheters and in a cleanroom environment. Experience with Lean Manufacturing and related principles and working directly with the engineers to make continuous improvement changes. Experience with maintaining accurate records including training files and shop floor paperwork. Experience training others. Experience working in a pre-production environment. Requisition ID: 633235 Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class. Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
Location: Temecula, CA Schedule: Full-time (36–40 hours/week) Compensation: $25-29/hr (DOE) Job Description We are a six-year-old, growing craft meadery seeking an experienced Brewer (Production & Operations) to oversee day-to-day mead production and bring consistency, structure, and accountability to our operations. This is a hands-on role in a small manufacturing environment. The right candidate is comfortable working independently, enforcing standards, and directing daily workflow without constant oversight. This role is designed to reduce owner involvement in daily production by placing clear authority and responsibility on-site. This is not an entry-level role and not a training position. Prior commercial production experience is required. Responsibilities Production & Brewing * Lead and participate in all mead production activities, including brewing, fermentation, cellaring, and packaging * Monitor fermentations (gravity, pH), assist with filtration, and oversee bottling, canning, and kegging runs * Maintain accurate batch records, cleaning logs, and production documentation * Ensure production timelines are met consistently and efficiently Quality Assurance & Sanitation * Own sanitation standards, QA execution, and SOP enforcement * Ensure all production areas remain clean, safe, and organized at all times * Identify, document, and resolve quality, process, or safety issues * Maintain compliance and QA documentation as required (e.g., certifications, food safety, labeling support) Operations & Inventory * Co-Plan production schedules to meet sales demand and inventory needs * Ensure raw materials, packaging, and supplies are stocked and available in advance * Coordinate with vendors, suppliers, and freight partners as needed * Maintain organized warehouse, cold storage, and equipment areas Team Leadership * Direct daily workflow of production staff * Enforce schedules, breaks, safety requirements, and SOP adherence * Provide clear, direct feedback and participate in regular performance check-ins * Escalate performance or process issues to ownership with recommendations Customer & Tasting Room Support (Limited) * Support tasting room operations or events during peak times as needed * Represent the meadery professionally when interacting with customers Decision Authority This role has authority to: * Set daily production priorities * Enforce SOPs and sanitation standards * Direct production staff workflow * Pause production if quality or safety standards are not met Ownership will support decisions made within this scope. Qualifications Required * 3-5 years experience in a commercial meadery, brewery, or winery, with 1+ year of leadership experience * Experience producing mead or beer/wine with transferable fermentation and cellar skills * Demonstrated experience leading or directing production or packaging teams * Strong organizational skills and attention to detail * Ability to manage production timelines, quality, and safety simultaneously * Comfort enforcing standards and giving clear, direct feedback * Willingness to perform hands-on work, including cleaning and sanitation * Ability to lift up to 100 lbs (e.g., honey buckets, full kegs) Preferred (Not Required) * Experience with QA, compliance, or production documentation * Familiarity with food safety, OSHA, or labeling requirements * Forklift or warehouse equipment experience * Comfort explaining fermentation or production processes to customers What This Role Is / Is Not This role is: * Hands-on * Structured * Accountable * Direct This role is not: * An entry-level or training position * A creative-only brewing role * A flexible side gig * A role without standards or authority How to Apply Please submit: * Your resume * A short note explaining: * *Your relevant production and leadership experience* * Why this role interests you * Your availability and compensation expectations Job Type: Full-time Pay: $26.00 - $29.00 per hour Benefits: * Employee discount Application Question(s): * Are you located within 10 miles of Temecula? If not, please explain your willingness to commute. * Please explain why you would like to work at Batch Mead (this question is very important to us!) Please feel free to send your cover letter (answers to these questions) and resume to [email protected]: * Do you have at least 3 years of experience producing/making alcohol in a commercial winery, brewery or meadery? (If not, please know that we are not able to consider you at this time): Work Location: In person
Quality Assurance Specialist Job Purpose The Quality Assurance Specialist is an experienced individual contributor who independently owns and operates defined Quality Management System processes and exercises judgment on routine and moderately complex quality and compliance matters. The position serves as a subject matter expert for assigned quality systems, drives timely resolution of quality events, supports product disposition and regulatory activities, analyzes quality system performance, and leads defined process improvements with minimal oversight. The QA Specialist works collaboratively with the QA Associate and Sr. Quality Systems Engineer. The QA Associate provides day-to-day administration for document control, training, and asset management, while the QA Specialist provides process expertise, escalation support, backup coverage, and quality-system oversight as assigned. The Sr. Quality Systems Engineer partners with the QA Specialist on complex investigations, risk management, system design, validation/CSA, statistical analysis, and cross-functional quality-system improvements. The QA Specialist does not have direct supervisory responsibility for the QA Associate unless specifically assigned. Batch Release Own and execute assigned batch release activities, ensuring release decisions and documentation are completed in accordance with approved procedures, product requirements, and applicable regulatory requirements. Evaluate routine release discrepancies and coordinate resolution or escalation of issues requiring additional technical, regulatory, or management review. Train and support qualified personnel in batch release procedures and Electronic Batch Record (EBR) capabilities as new systems are introduced. Partner with Operations and the Sr. Quality Systems Engineer to model, implement, and improve EBR processes and associated controls. Quality Events – NCMR, DeviationCAPA Serve as process owner or primary QA subject matter expert for assigned NCMR, deviation, and CAPA processes, ensuring records are appropriately initiated, investigated, reviewed, approved, and closed within established timelines. Triage quality issues raised across the organization and determine the appropriate quality-system pathway, escalation, and required follow-up. Lead or support investigations and structured root cause analysis for routine and moderately complex quality events; partner with the Sr. Quality Systems Engineer and technical functions on complex, systemic, or cross-functional investigations. Assess quality events for potential impact to released product, product disposition, validation status, regulatory commitments, and risk management activities, escalating as appropriate. Drive CAPA timelines, evaluate adequacy of corrections/corrective actions and effectiveness activities, and train employees on successful execution of quality event processes. Monitor quality event trends and recommend systemic actions or process improvements when adverse or recurring patterns are identified. Asset Management – Process Oversight Serve as QA process owner/subject matter expert for the calibration and preventive maintenance quality system, with day-to-day scheduling, record maintenance, and tracking administered by the QA Associate. Review and assess overdue, out-of-tolerance, incomplete, or otherwise non-conforming asset situations and determine or coordinate required quality-system actions. Provide training, procedural guidance, and backup coverage for asset management activities and drive improvements to the calibration/preventive maintenance process. Partner with the Sr. Quality Systems Engineer and equipment owners on qualification, validation, technical assessments, or systemic equipment-control issues as appropriate. Regulatory SubmissionInspection Support Research, organize, analyze, and present historical quality and manufacturing data in support of FDA submissions and responses to agency questions, including PMA-related activities. Support preparation for FDA inspections, Notified Body audits, ISO 13485 audits, customer audits, supplier audits, and internal audits. Lead or support audit backroom activities, including request management, record retrieval coordination, response tracking, and communication with subject matter experts. Serve as a Quality Assurance subject matter expert during audits and inspections for assigned quality-system processes. Risk Management, StandardsQuality Engineering Partnership Ensure relevant quality events and post-production information are evaluated for potential linkage to product risk management activities. Partner with the Sr. Quality Systems Engineer and technical functions on updates to Risk Management Files, risk probabilities, and other ongoing risk-management activities. Apply structured Root Cause Analysis methodologies and appropriate data analysis to quality investigations; engage the Sr. Quality Systems Engineer for complex statistical, technical, or systemic analyses. Support gap analyses of new and revised standards and regulations applicable to company products and quality systems in partnership with the Sr. Quality Systems Engineer and Regulatory Affairs. Participate in implementation of resulting quality-system changes and verify completion of assigned actions. Document Control, TrainingeQMS Serve as a subject matter expert and escalation resource for document control and training processes administered day-to-day by the QA Associate. Provide backup coverage for document control, training administration, and related quality records when needed and appropriately trained. Review or approve controlled documents within assigned authority and provide guidance to authors and process owners on Quality System requirements. Conduct or coordinate GMP/QMS and process-specific training as assigned. Partner with the QA Associate and Sr. Quality Systems Engineer on eQMS implementation, migration, workflow design, testing, validation/CSA activities, and ongoing process improvement. Define or contribute Quality Assurance requirements for eQMS workflows involving quality events, document control, training, batch release, and other assigned processes. Update SOPs and Work Instructions to align with approved quality-system and eQMS processes. Audits, MetricsQuality System Improvement Schedule and coordinate the internal audit program as assigned and support remediation and closure of audit findings. Compile, analyze, and present monthly quality metrics and identify trends requiring management attention or further investigation. Compile and analyze information for Management Review and support preparation of Quality Management System performance summaries. Lead defined quality-system improvement projects and track action items, timelines, risks, and deliverables. Provide quality guidance to Operations, Product Development, and other functions on assigned Quality System processes and escalate decisions outside assigned authority. Cross-Functional CoordinationBackup Coordinate closely with the QA Associate to maintain continuity of document control, training, asset management, and other assigned Quality Assurance processes; provide cross-training and backup coverage without direct supervisory responsibility. Interface routinely with the Sr. Quality Systems Engineer on investigations, risk management, validation/CSA, eQMS implementation, standards, data analysis, and systemic quality improvements. Train and guide personnel on assigned Quality System processes and may provide functional direction for specific activities or projects. Perform other duties and quality projects as assigned. Skills / Qualifications Bachelor's degree in a scientific, engineering, technical, or related discipline and typically 3–5 years of Quality Assurance/Regulatory Affairs experience in a regulated industry; medical device highly preferred. Relevant experience may be accepted in lieu of degree. Working knowledge of ISO 13485 and 21 CFR Part 820 (Quality Management System Regulation/QMSR); exposure to FDA submission processes, including PMA activities, preferred. Familiarity with ISO 14971 risk management principles, structured Root Cause Analysis methodologies, and quality-system data analysis. Demonstrated ability to independently manage quality-system processes such as CAPA, NCMR/deviation, calibration/preventive maintenance oversight, document/training systems, or batch release with minimal supervision. Experience supporting regulatory, Notified Body, customer, or internal audits and ability to serve as a subject matter expert for assigned processes. Strong analytical, problem-solving, written, and verbal communication skills, including the ability to train and guide personnel and communicate quality issues to cross-functional stakeholders. Proficiency with Microsoft Word, Excel, PowerPoint, and electronic Quality Management Systems (eQMS). Ability to balance independent process ownership with effective collaboration, escalation, and cross-functional decision-making. Positive, collaborative, and accountable working style with willingness to take on additional tasks and projects as assigned.
Quality Assurance Associate – Document Control, Training, and Asset Management Job Purpose The Quality Assurance Associate supports the effective operation of the Quality Management System through accurate and timely administration of document control, training, equipment calibration/preventive maintenance, and related quality records. The position is responsible for executing established quality system processes, maintaining required logs and records, monitoring routine due dates, and escalating issues in accordance with approved procedures. The QA Associate works collaboratively with the QA Specialist and Sr. Quality Systems Engineer. The roles are expected to coordinate closely and provide cross-training and backup support for assigned processes; however, the QA Associate does not report to the QA Specialist. The position operates under departmental management and escalates quality decisions requiring independent technical or compliance judgment. Document ControlRecords Administration Administer day-to-day document control activities, including processing document change requests, routing documents for review and approval, issuing effective documents, maintaining controlled copies, and archiving superseded records in accordance with approved procedures. Perform document quality control checks for formatting, required approvals, metadata, references, and completeness; promptly communicate irregularities and coordinate correction prior to release. Maintain controlled Quality System documents and records, including SOPs, Work Instructions, forms, specifications, drawings, batch records, protocols, reports, and other applicable technical documentation. Support authors and process owners with document templates, document numbering, routing requirements, and document control procedures. Maintain external standards and regulatory reference records applicable to manufacturing, quality, and design activities. Support document migration and data verification activities associated with implementation and maintenance of the electronic Quality Management System (eQMS). Training Administration Administer the training system, including assignment of required training, maintenance of training curricula and records, tracking of completion, and follow-up on overdue training. Coordinate training assignments resulting from new or revised controlled documents and verify completion before or following document effective dates as required by procedure. Support preparation of training status reports and escalate overdue or incomplete training to responsible managers and Quality management. Provide routine user support for the training system and assist with eQMS training administration. Asset Management – CalibrationPreventive Maintenance Administer the equipment calibration and preventive maintenance program, including maintenance of the asset database, scheduling, due-date tracking, and coordination with internal personnel and outside service providers. Collect and maintain calibration, preventive maintenance, qualification, and service records and perform defined administrative/documentation checks for completeness. Monitor upcoming and overdue calibration and preventive maintenance activities and escalate overdue, missing, or potentially non-conforming equipment records to the QA Specialist, Sr. Quality Systems Engineer, or Quality management as appropriate. Support equipment status labeling and other routine asset-control activities in accordance with approved procedures. Quality System Support Maintain quality system logs and trackers and support collection of data used for quality metrics and Management Review. Provide administrative support for NCMR, deviation, CAPA, complaint, audit, and other quality system records, including record initiation, routing, tracking, filing, and follow-up as assigned. Support batch release activities through record compilation, document verification, and other assigned activities performed in accordance with approved procedures and authorization levels. Retrieve records and documentation in support of internal, external, customer, Notified Body, and FDA audits or inspections. Support implementation, migration, testing, and ongoing administration of eQMS workflows in coordination with the QA Specialist and Sr. Quality Systems Engineer. Identify recurring administrative issues or opportunities for process improvement and communicate them to process owners and Quality management. Provide backup support for defined QA Specialist activities when trained and authorized. Perform other duties and quality projects as assigned. Skills / Qualifications Bachelor's degree in a scientific, technical, business, or related discipline preferred; relevant education and experience may be accepted in lieu of a degree. 0–2 years of experience in Quality Assurance, document control, regulated manufacturing, or a related function preferred. Medical device or pharmaceutical experience is desirable. Basic knowledge of, or ability to learn, ISO 13485 and 21 CFR Part 820 (Quality Management System Regulation/QMSR). Exposure to 21 CFR Parts 210/211 and Part 4 for combination products is desirable. Strong attention to detail and demonstrated ability to maintain accurate records, manage multiple due dates, and follow established procedures. Strong written and verbal communication skills and ability to coordinate effectively with employees at all organizational levels. Proficiency with Microsoft Word, Excel, PowerPoint, and electronic document or quality management systems; eQMS experience preferred. Ability to recognize and escalate discrepancies, overdue activities, or situations requiring Quality review. Positive, collaborative, and dependable working style with willingness to cross-train and provide backup support across Quality Assurance activities.
Fabric8Labs, headquartered in sunny San Diego, CA, is revolutionizing advanced manufacturing with next-generation 3D printing technology. We're looking for a *Systems Engineer* as we scale our patented Electrochemical Additive Manufacturing (ECAM) process for global production. ECAM uses precise, room-temperature metal deposition to unlock geometries and applications that conventional metal AM can't achieve. Since announcing our agreement to be acquired by TDK Corporation, we're rapidly expanding our team to advance this disruptive technology across a wide range of electronics components—including data center infrastructure, wireless communications, and power electronics. As a *Systems Engineer*, you’ll contribute to the company’s efforts to push the boundaries of ECAM technology by advancing the quality of our printer manufacturing and maintenance processes. You’ll troubleshoot complex mechanical, electrical, and software issues, identify root causes, and develop solutions to improve the printer fleet’s performance. This will involve structured problem-solving methods to solve technical challenges and driving continuous improvement. Your insights and solutions will be leveraged across the current printer fleet and incorporated into future generations of printers. This is a fast-paced, intellectually challenging position that requires strong analytical skills, critical thinking, and the ability to manage multiple priorities. We’re changing the manufacturing industry, and we’re looking for someone who thrives in a dynamic R&D environment while helping establish the quality systems and processes needed to successfully scale into production. *Primary Responsibilities:* * Analyze manufacturing and quality data to identify trends, drive root cause investigations, and implement corrective and preventive actions (CAPA). * Apply structured problem-solving methodologies (8D, 5 Whys, Fishbone, etc.) to resolve product and process quality issues. * Drive continuous improvement initiatives using data-driven decision making and statistical analysis to improve factory KPIs * Track system-level performance metrics and reliability targets. * Support continuous improvement efforts on existing equipment, identifying reliability and performance enhancements * Partner with mechanical, electrical, and software engineers to ensure seamless system integration across hardware and controls layers * Develop, maintain, and improve documentation, including standard operating procedures (SOPs) and work instructions * Develop and execute functional test plans to validate machine behavior and corrective actions * Participate in design reviews and contribute to system documentation, schematics, and ECO activities. *Required Skills and Experience:* * Bachelor's degree in Mechanical Engineering, Electrical Engineering, Computer Science, Mechatronics, or another relevant technical discipline. A Master's degree is a plus. * 0–5 years of experience in field engineering, mechanical engineering, electrical engineering, manufacturing engineering, or a related technical role. * Comfort working hands on with electrical, mechanical, and software systems * Experience creating and maintaining manufacturing documentation such as SOPs and work instructions * Knowledge of quality tools and methodologies, including root cause analysis, CAPA, FMEA. * Hands-on experience troubleshooting manufacturing or electromechanical systems is preferred. * Working knowledge of CAD (solidworks, Onshape) * Familiarity with python and Linux is preferred * Experience with engineering change management, and ECO implementation plans. * Strong communication skills with the ability to collaborate effectively across engineering, manufacturing, and operations teams. * Highly organized with the ability to manage multiple projects and priorities in a fast-paced environment. *Why Work at Fabric8Labs?* * We offer a comprehensive benefits package, health, dental, and vision plans; 401(k) with employer match; and an unmetered vacation policy. * We have a collaborative work environment where we work in tight-knit teams focused on transforming manufacturing technology. * Regular catered company events and celebrations, and a fully stocked breakroom! *Other information* * Routinely required to sit; walk; talk; hear; use hands to type, handle, and feel; stoop, kneel, crouch, twist, reach, and stretch. Routinely required to move around the facility. * Occasionally lift and/or move up to 40 pounds. * May require travel (domestic and/or international) dependent on business needs, up to 10%. * Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus. * This position will start in Sorrento Valley and will likely require work in Palomar area _Fabric8Labs is an equal opportunity employer. We are committed to diversity and inclusion in the workplace. Fabric8Labs prohibits discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws._ Job Type: Full-time Pay: $75,000.00 - $130,000.00 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Flexible schedule * Health insurance * Paid time off * Parental leave * Vision insurance Experience: * engineering: 5 years (Required) Ability to Relocate: * San Diego, CA 92121: Relocate before starting work (Required) Work Location: In person
*Job Summary* We are seeking a skilled and detail-oriented Fabricator to join our dynamic manufacturing team. In this role, you will be responsible for transforming raw materials into precise, high-quality metal components and assemblies using a variety of fabrication techniques and machinery. Your expertise will ensure that all products meet strict quality standards, safety protocols, and technical specifications. This position offers an exciting opportunity to contribute to innovative projects in a fast-paced environment where craftsmanship and precision are paramount. *Duties* * Operate and set up a wide range of fabrication machinery including CNC laser cutters, CNC milling machines, CNC lathes, plasma cutters, press brake machines, stamping presses, and electrical discharge machining equipment. * Interpret mechanical blueprints, technical drawings, and GD&T (Geometric Dimensioning & Tolerancing) specifications to accurately produce components. * Use hand tools, measuring instruments, and precision measurement devices to verify dimensions and ensure quality control throughout the fabrication process. * Perform metal forming, sheet metal fabrication, welding, and assembly tasks with attention to safety standards in production. * Program CNC machines for efficient manufacturing processes and troubleshoot machine operation issues as they arise. * Maintain a clean and safe work environment by adhering to safety protocols and conducting routine inspections of tools and equipment. * Collaborate with team members on project timelines, ensuring all parts are fabricated to meet quality standards and technical specifications. *Qualifications* * Proven experience operating CNC laser cutting machines, CNC milling machines, CNC lathes, plasma cutters, press brakes, stamping presses, and other forming or machining tools. * Strong mechanical knowledge with the ability to interpret mechanical blueprints and technical drawings accurately. * Proficiency in using measurement instruments such as calipers, micrometers, gauges, and other precision measurement tools for quality inspection. * Knowledge of shop math including basic calculations necessary for machining and fabrication tasks. * Skilled in welding techniques including MIG, TIG or stick welding; experience with electrical discharge machining is a plus. * Ability to operate hand tools and tooling equipment safely while maintaining high standards of craftsmanship. * Familiarity with safety standards in manufacturing environments including proper machine setup and safety protocol adherence. * Mechanical aptitude combined with excellent problem-solving skills to troubleshoot machine issues quickly. * Strong communication skills for effective teamwork and understanding technical instructions. Join our team as a Fabricator if you’re passionate about metal fabrication, eager to develop your skills in a vibrant manufacturing environment, and committed to producing top-quality products safely! Pay: $30.00 - $35.00 per hour Benefits: * 401(k) * Dental insurance * Health insurance * Life insurance * Paid time off * Vision insurance Work Location: In person
*About Us* L.F. Industries, Inc. is a dynamic manufacturing shop committed to delivering high-quality products on time. We are seeking a dedicated Production Supervisor to lead our shop floor, maintain our rigorous quality standards, and drive operational efficiency. *Job Summary* We are looking for an experienced and highly organized Production Supervisor to oversee daily shop operations. The ideal candidate will take a hands-on approach to leadership, ensuring that manufacturing runs smoothly from receiving parts to final quality inspection. You will be responsible for managing personnel, maintaining an organized and safe work environment, prioritizing jobs to meet production schedules, and leading our quality department. *Key Responsibilities* * Schedule new jobs and ensure shop employees are prioritizing tasks correctly to meet operational deadlines and customer expectations. * Oversee the receiving of incoming parts and materials, ensuring accurate inventory flow to the production floor. * Assign tasks to employees based on production needs and individual skill levels. * Oversee and manage the Quality Department to ensure all products meet strict company and customer standards. * Perform first article inspections (FAI) and in-process part inspections as required during production runs. * Identify quality issues early in the manufacturing process and implement corrective actions. * Ensure all required production and quality documentation, logs, and compliance records are accurately filled out and maintained. * Monitor standard operating procedures (SOPs) and ensure all staff are strictly following manufacturing guidelines. * Ensure all work areas are clean, well-maintained, and comply with safety and organization standards (e.g., 5S methodology). * Develop, manage, and assign equipment maintenance schedules to prevent downtime and extend machinery lifespan. * Perform various shop organization tasks to optimize floor space and workflow efficiency. *What We’re Looking For* * Previous supervisory or management experience in a manufacturing or machine shop environment. * Strong background in quality control, including experience with first article and in-process inspections. * Ability to read and interpret technical drawings, blueprints, and specifications. * Excellent organizational skills with a proven track record of managing production schedules and prioritizing jobs. * Familiarity with preventative maintenance scheduling. * Strong communication and leadership skills to effectively manage and motivate shop employees. * Detail-oriented mindset with strict attention to proper documentation. *Physical Demands* * Ability to stand and walk on the shop floor for extended periods. * Must be able to lift and move materials up to 50 lbs when necessary. * Exposure to standard manufacturing environments, including noise and moving machinery (proper PPE required). *Why Join Us?* * Competitive pay * Work in a clean, well-equipped, and collaborative shop environment. * Be part of a company where your skill and independence are valued. * Opportunities to grow alongside a stable and respected precision machining company. Pay: $72,800.00 - $95,000.00 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Health insurance * Life insurance * Paid time off * Profit sharing * Vision insurance People with a criminal record are encouraged to apply Work Location: In person