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*Medical Device Assembler (San Diego, California) * GI Bionics, LLC is a startup company focused on bringing gastrointestinal medical devices to market. Our unique facility enables rapid design, prototyping, and on-site in-vivo testing of medical devices. GI Bionics brings together researchers, clinicians, engineers, and technicians to address the significant health care challenges of metabolic disorders through a deep understanding of organ systems and medical device development. We are seeking an assembler with a strong background in medical device manufacturing. This person will apply a high level of hands-on technical skill in constructing and testing electro-mechanical medical devices. Responsibilities include fabrication of prototypes, production product, bench-top testing, and filling out documentation to ensure device traceability. We work in a lively team-oriented environment that offers the opportunity to make real impacts in human health through the diagnosis and treatment of diseases. This person will be an essential part of that team. *Key Responsibilities* · Perform product assembly and testing to GMP standards. Able to carefully follow manufacturing instructions and document all procedures and results. · Read and interpret engineering drawings, schematics and complex test procedures. Can write basic procedures and technical documents. Microsoft Word and Excel experience is beneficial. · Able to work independently. Follows established procedures. · Familiarity with soldering and use of hand tools is much preferred. · Familiarity with assembly of catheter or infusion delivery sets in a cleanroom environment is beneficial. · Ability to work using moderate visual magnification assist devices (e.g. inspection microscopes, etc.). *Basic Qualifications:* Prior medical or defense device industry experience. No relocation compensation. *Experience Required:* This position requires a minimum of five years of related technical experience, with more preferred. *Salary and Benefits:* We offer a competitive salary commensurate with level of experience and demonstration of skills. Performance-based equity incentives available. Benefits include comprehensive medical, dental, and vision insurance. Also, three weeks of paid time off. GI Bionics, LLC is an Equal Opportunity Employer. Our policy prohibits discriminatory practices or harassment against applicants or employees based on any legally impermissible basis including, but not necessarily limited to, race, color, religion, national origin, gender, age, sexual orientation, gender identity or expression, marital status, mental or physical disability, genetic information, family status, pregnancy, or any other basis protected by applicable law. Pay: $24.98 - $26.98 per hour Benefits: * AD&D insurance * Dental insurance * Health insurance * Life insurance * On-site gym * Paid time off * Vision insurance Experience: * medical device : 5 years (Required) Ability to Commute: * San Diego, CA 92121 (Required) Work Location: In person
Who We Are ABOUT ENOVIS™ Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com. What You'll Do At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it. Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? See for yourself. As a key member of the Vista Manufacturing Center, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. Job Title: Assembler Reports To: Production Manager Location: Vista, CA Business Unit Description: Enovis Bracing and Supports Job Title/High Level Position Summary: Production Assembler under close supervision uses written procedures to perform all the steps required to assemble knee braces and related products. Ensures quality and product conformance based on the order specifications. Complies with established guidelines, work instructions, and company policies. Performs maintenance responsibilities to keep area clean and safe. Performs various tasks which may include but are not limited to: Key Responsibilities: Use of power tools, hand tools and universal fixtures to assemble knee braces and related medical products. Being able to maneuver up to 50lbs. Standing all day Withstand hot and cold temperatures. Sanding to prepare surfaces for paint. Preparing and mixing paint. Ability to cut materials per established guidelines. Participate on manufacturing audits and 5S program. Inform supervisor or lead of work-related problems. Be willing to work over-time and Saturday’s. Work in a team-oriented environment Demonstrates an understanding of basic assembly techniques and approaches. Overtime and Saturday flexibility Minimum Basic Qualifications: Proficient with reading and understanding blueprints, assembly drawings and bills of materials. Strong communication and organizational skills including communicating at multiple levels in the organization. Ability to work in a team-oriented environment. Travel Requirements: N/A Desired Characteristics: Strong communication, organizational skills, and ability to work in a team-oriented environment Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship. “Creating better together”. It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes. Watch this short video and discover what creating better together means to us at Enovis: Our Enovis Purpose, Values and Behaviors on Vimeo We offer a comprehensive benefits package which includes: Medical Insurance Dental Insurance Vision Insurance Spending and Savings Accounts 401(k) Plan Vacation, Sick Leave, and Holidays Income Protection Plans Discounted Insurance Rates Legal Services Join us in creating better together. #LI-RC2 EQUAL EMPLOYMENT OPPORTUNITY Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.
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. With limited supervision, this position is responsible for supporting engineering and manufacturing as a liaison to expedite the design and development process. Evaluates and resolves complex engineering related production problems related to manufacturing, design, quality and material engineering. Serves as an external spokesperson through correspondence with vendors and subcontractors to ensure delivery dates and company objectives are met. Exercises considerable latitude in determining objectives and approaches to assignments and develops solutions to complex problems. This position involves the exercise of independent judgment and discretion about matters of significance. DUTIES & RESPONSIBILITIES: Ensures parts and purchase requisitions are processed through the system in a timely manner. Ensures delivery dates are met by maintaining frequent contact with all critical subcontractors and vendors. Analyzes engineering specifications and drawings. Confers across functional areas to provide and obtain technical information. Coordinates and monitors the design and development process by making periodic visits to various departments such as manufacturing shops, quality assurance, sales, MRB cribs, planning, purchasing, manufacturing engineering and electrical engineering. Coordinates engineering priorities for manufacturing issues, and ensures schedule parity. Advises management of the status of work in progress and identifies potential production problems. Ensures rapid disposition of engineering holds and lift orders. Coordinates Manufacturing Service Request activities by resolving priority schedule conflicts among engineering departments due to shop capacity limitations and resolving shop capacity issues with manufacturing and planning. Reviews and recommends resolutions for open engineering issues affecting sales orders. Alerts planning department to open engineering issues that may affect manufacturing. Alerts engineering departments to sales order activity which may affect outstanding work. May function in an advisory or leadership role and provide direction and guidance to less experienced staff. Maintains the strict confidentiality of sensitive information. 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. Additional Functions 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 degree in business, planning or a related discipline and five or more years of progressive experience in planning, coordinating and scheduling production operations. May substitute equivalent experience in lieu of education. Must demonstrate an extensive understanding of planning and production operation theories, concepts and principles and experience demonstrating a broad application of those concepts. Must possess leadership skills including organizing, scheduling, conducting, and coordinating work assignments to meet project milestones or established completion dates. Must possess: The ability to identify issues, analyze and interpret data and develop innovative solutions to a variety of complex problems. Excellent analytical, verbal and written communication skills to accurately document, report, and present findings. Excellent interpersonal skills to influence and guide others. The ability to contribute to the development of new processes or systems and communicate new concepts. Excellent computer skills. The ability to work independently or in a team environment is essential as is the ability to work extended hours and travel as required. Job Category Manufacturing Experience Level Mid-Level (3-7 years) Workstyle Onsite Full-Time/Part-Time Full-Time Salary Pay Range Low 68,770 Pay Range High 116,193 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? No Search Jobs at | General Atomics and Affiliated Companies
*Reuts Yogurt* is looking for a reliable, detail-oriented team member to help with our yogurt production and packaging operations. This is a great opportunity for someone who enjoys hands-on work in a small food production environment and wants to be part of a growing local brand. *No prior experience required — we will train you!* Responsibilities: * Apply expiration date labels to yogurt cups * Fill and seal yogurt cups using our packaging equipment * Build and pack product cases for distribution * Maintain a clean and organized production workspace * Assist with end-of-day cleaning and sanitation tasks * Follow food safety and quality standards Qualifications: * Reliable and punctual * Comfortable working on your feet and performing repetitive tasks * Strong attention to detail and ability to follow instructions * Positive attitude and willingness to learn * Food production experience is a plus, but not required Schedule & Pay: * *Part-time: Tuesdays–Thursdays 4PM-7PM* * *$18/hour* About Reuts: Reuts makes small-batch yogurt cultured with _L. reuteri_, one of the most studied probiotic strains. We are a growing local company focused on creating high-quality, functional foods and bringing better-for-you yogurt to our community. *To apply, please send your name and a brief introduction.* Pay: Up to $18.00 per hour Work Location: In person
The Quality Engineer I is responsible for risk analysis, control plans, inspection, supplier quality, and metrology methodology activities. They also ensure customer requirements are defined and all project deliverables meet customer, internal and regulatory requirements including all applicable standards. Learn manufacturing processes and actively participate in continuous improvement initiatives to enhance quality, efficiency, and cost performance using Lean/Six Sigma methodologies Support the nonconforming material process by documenting nonconformances, participating in Material Review Board (MRB) activities, tracking dispositions to closure, and contributing to containment actions, root cause investigations, corrective actions, and Cost of Poor Quality (COPQ) metrics Collect, compile, and analyze quality data (e.g., yield, scrap, rework, and defect trends); prepare charts and reports for quality leadership; and participate in internal and customer reviews, presentations, and discussions to support quality improvement initiatives Assist in the development and maintenance of inspection plans, quality records, and workmanship documentation in accordance with AS9100D and customer requirements Support supplier quality activities by documenting supplier nonconformances and compiling supplier performance metrics Learn and apply electronic assembly workmanship standards, including IPC-A-610, IPC-A-620, and J-STD-001, through formal training and hands-on manufacturing experience Support compliance with ESD (ANSI/ESD S20.20), Foreign Object Debris (FOD) prevention, and counterfeit parts prevention activities Assist in compiling, auditing, and maintaining product compliance documentation, including End Item Data Packages (EIDPs), First Article Inspection (FAI) documentation per AS9102, source inspection records, and other quality documentation Lead corrective actions, including changes to procedures to ensure completeness and currency Support internal audits and assist with customer, DCMA, and third-party AS9100D audits Support root cause and corrective action (RCCA) investigations using structured problem-solving tools, including 5 Whys and fishbone diagrams, under the guidance of senior engineers Bachelor's Degree in Mechanical Engineering, Quality Engineering, Electrical Engineering or related field of study No experience is required or (4) years of experience may be considered in lieu of a Bachelors Degree Ability to obtain and/or maintain a Security Clearance About Frontgrade At Frontgrade, we build mission-critical electronics that perform without compromise in the world’s most demanding environments, from deep space to national defense. With decades of proven heritage, we deliver high-reliability components, subsystems, and integrated solutions trusted when failure is not an option. But our strength is not just in what we build. It is in the people who make it possible. From engineers and product managers to sales teams, marketers, and skilled manufacturing professionals, every role plays a direct part in enabling missions that protect, explore, and connect our world. We move with purpose, collaborate across disciplines, and take pride in delivering solutions our customers rely on in the highest-stakes environments. If you want your work, whatever your specialty, to contribute to something bigger, you will find your place at Frontgrade. Why Work for Us We believe mission success starts with taking care of our people. That’s why we offer competitive health, wealth, and wellbeing benefits from day one. You’ll also find real opportunities to learn, grow, and advance, whether you’re building technical expertise, leading teams, or expanding into new areas. Here, your growth is part of the mission. Additional Information This position may require access to technology, materials, software or hardware that is controlled by either ITAR or EAR U.S. export laws. As a condition of any job offer, in order to be employed in this position, you may need to obtain a U.S. Government export license(s), as required by law. Other benefits include: Immediate Medical (FSA and HSA), Dental, and Vision 401K Match with 100% immediate vesting 9X80 compressed work schedule for qualifying roles Career Opportunity and Growth Tuition Reimbursement/Student Loan Repayment Generous PTO and 11 paid Holidays per year (9 designated holidays and 2 floating holidays) 8 weeks of 100% Paid Family Leave
General Summary: Completes general activities on the production floor. Benefits and Culture We offer a competitive compensation and benefits package designed to help employees live a healthier life, build rewarding careers and save for the future. Reser's offers choices whenever possible, because we recognize the diverse and ever changing needs of our employees. Benefits include medical, dental, vision, AD&D, life, 401(k) with discretionary match, wellness programs, paid holidays and vacation time to name few! We strive to be your Employer of Choice. As one of our five cornerstones, this means that we go all-out to create an environment where people choose a lasting career because Reser’s care about their personal development & safety, and delivers a rewarding work experience. Visit our website to learn more about our competitive benefit programs - https://www.resers.com/careers/#benefits Principal Duties and Responsibilities 1. Assists with production, preparation, and storage of company products. 2. Places boxed products on a pallet. 3. Maintains housekeeping of the production plant and warehouse. 4. Follows company safety guidelines and Good Manufacturing Practices. Job Specifications 1. Must be able to follow directions. 2. English/Spanish bilingual is a plus. Working Conditions 1. Refrigerated food manufacturing plant. 2. The environment may be wet, or dry, and temperatures may range from 25°F to 110°F. 3. Repetitive lifting, kneeling, and bending with packages in excess of 35 lbs is required. 4. Requires walking and standing for long periods of time. 5. Production demands may require overtime and/or evening or weekend scheduling. Compensation: $17.50 + $1.00 shift differential per hour/non-exempt. Recipe for Success Reser’s is the leading provider of fresh refrigerated deli salads, side dishes, and prepared foods for the supermarket, club store, and food service industries. Family owned and operated, Reser’s has been a proud sponsor of good times at racetracks, picnics, BBQs, music festivals, and affordable family meals since 1950. Reser’s family of brands include Reser’s American Classics, Main St Bistro, Stonemill Kitchens, and more. With more than 4,500 employees, Reser’s operates 14 facilities in the US, Mexico, and Canada and actively supports the communities it serves. 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.
General Summary: Operates food processing machines that produce food products. Benefits and Culture We offer a competitive compensation and benefits package designed to help employees live a healthier life, build rewarding careers and save for the future. Reser's offers choices whenever possible, because we recognize the diverse and ever changing needs of our employees. Full-time employee benefits include medical, dental, vision, AD&D, life, 401(k) with discretionary match, wellness programs, paid time off, company paid holidays and a variety of voluntary benefit options. We strive to be your Employer of Choice. As one of our five cornerstones, this means that we go all-out to create an environment that shows we are committed to investing in employee growth and creating a culture of belonging where employees want to build a lasting career. Visit our website to learn more about our competitive benefit programs - https://www.resers.com/careers/#benefits Principal Duties and Responsibilities 1. Operates a machine and ensures quality and conformity of packaged products. 2. Helps to assemble and configure machine according to current specifications. 3. Ensures correct consumables loaded for the product being run. 4. Maintains covering carts and hopper as necessary. 5. Checks for correct packaging materials. 6. Prepares unused for put away at the end of a run, including putting a count on the case. 7. Detects and reports defective materials, machine problems or questionable conditions to the machine operator immediately and to maintenance department as needed. 8. Maintains necessary machine supplies, work area and equipment in a clean orderly condition. 9. Washes and resets equipment during product changes per SOP. 10. Troubleshoots downtime issues. 11. Displays positive attitude toward people, equipment, and company policy. 12. Follows company safety guidelines, HACCP requirements and Good Manufacturing Practices. 13. Regular attendance and punctuality are required due to working with people, items and equipment that are at the facility. Job Specifications 1. Experience operating machinery is required. 2. Food industry experience is preferred. 3. Must be able to read, write, and speak English and be understood. 4. English/Spanish bilingual a plus. Working Conditions 1. Refrigerated food manufacturing plant. 2. The environment may be wet or dry and temperatures may range from 25°F to 110°F. 3. Requires walking and standing for long periods of time. 4. Repetitive lifting, kneeling, and bending with packages in excess of 50 lbs. is required. 5. Production demands may require overtime and/or evening or weekend scheduling. Compensation $23.00 per hour + $1.00 shift differential/non-exempt Recipe for Success Reser’s is the leading provider of fresh refrigerated deli salads, side dishes, and prepared foods for the supermarket, club store, and food service industries. Family owned and operated, Reser’s has been a proud sponsor of good times at racetracks, picnics, BBQs, music festivals, and affordable family meals since 1950. Reser’s family of brands include Reser’s American Classics, Main St Bistro, Stonemill Kitchens, and more. With more than 4,500 employees, Reser’s operates 14 facilities in the US, Mexico, and Canada and actively supports the communities it serves. 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.
General Summary: Packages finished food products at the end of the manufacturing process. Benefits and Culture We offer a competitive compensation and benefits package designed to help employees live a healthier life, build rewarding careers and save for the future. Reser's offers choices whenever possible, because we recognize the diverse and ever changing needs of our employees. Full-time employee benefits include medical, dental, vision, AD&D, life, 401(k) with discretionary match, wellness programs, paid time off, company paid holidays and a variety of voluntary benefit options. We strive to be your Employer of Choice. As one of our five cornerstones, this means that we go all-out to create an environment that shows we are committed to investing in employee growth and creating a culture of belonging where employees want to build a lasting career. Visit our website to learn more about our competitive benefit programs - https://www.resers.com/careers/#benefits Principle Duties and Responsibilities 1. Checks for correct packaging boxes and containers. 2. Ensures product date and weight are within established guidelines. 3. Seals filled product packages and boxes. 4. Examines containers, materials, and products to ensure packaging meet company specifications. 5. Removes defective products or packages from the production line. 6. Assembles product containers on an assembly line. 7. Maintains a clean and organized work area. 8. Follows company safety guidelines and Good Manufacturing Practices. 9. Regular attendance and punctuality are required due to working with people, items and equipment that are at the facility. Job Specifications 1. Production or assembly experience is preferred. 2. English/Spanish bilingual a plus. Working Conditions 1. Refrigerated food manufacturing plant. 2. The environment will be wet and cold with temperatures ranging from 25°F to 110°F. 3. Repetitive hand, wrist, and finger activities. 4. Repetitive lifting, kneeling, and bending with items in excess of 20 lbs. is required. 5. Requires walking and standing for long periods of time. 6. Production demands may require overtime and/or evening or weekend scheduling. Compensation: $17.50 + $1.00 shift differential per hour/ non-exempt. Recipe for Success Reser’s is the leading provider of fresh refrigerated deli salads, side dishes, and prepared foods for the supermarket, club store, and food service industries. Family owned and operated, Reser’s has been a proud sponsor of good times at racetracks, picnics, BBQs, music festivals, and affordable family meals since 1950. Reser’s family of brands include Reser’s American Classics, Main St Bistro, Stonemill Kitchens, and more. With more than 4,500 employees, Reser’s operates 14 facilities in the US, Mexico, and Canada and actively supports the communities it serves. 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.
General Summary: Operates food processing machines that produce food products. Benefits and Culture We offer a competitive compensation and benefits package designed to help employees live a healthier life, build rewarding careers and save for the future. Reser's offers choices whenever possible, because we recognize the diverse and ever changing needs of our employees. Full-time employee benefits include medical, dental, vision, AD&D, life, 401(k) with discretionary match, wellness programs, paid time off, company paid holidays and a variety of voluntary benefit options. We strive to be your Employer of Choice. As one of our five cornerstones, this means that we go all-out to create an environment that shows we are committed to investing in employee growth and creating a culture of belonging where employees want to build a lasting career. Visit our website to learn more about our competitive benefit programs - https://www.resers.com/careers/#benefits Principal Duties and Responsibilities 1. Operates a machine and ensures quality and conformity of packaged products. 2. Helps to assemble and configure machine according to current specifications. 3. Ensures correct consumables loaded for the product being run. 4. Maintains covering carts and hopper as necessary. 5. Checks for correct packaging materials. 6. Prepares unused for put away at the end of a run, including putting a count on the case. 7. Detects and reports defective materials, machine problems or questionable conditions to the machine operator immediately and to maintenance department as needed. 8. Maintains necessary machine supplies, work area and equipment in a clean orderly condition. 9. Washes and resets equipment during product changes per SOP. 10. Troubleshoots downtime issues. 11. Displays positive attitude toward people, equipment, and company policy. 12. Follows company safety guidelines, HACCP requirements and Good Manufacturing Practices. 13. Regular attendance and punctuality are required due to working with people, items and equipment that are at the facility. Job Specifications 1. Experience operating machinery is required. 2. Food industry experience is preferred. 3. Must be able to read, write, and speak English and be understood. 4. English/Spanish bilingual a plus. Working Conditions 1. Refrigerated food manufacturing plant. 2. The environment may be wet or dry and temperatures may range from 25°F to 110°F. 3. Requires walking and standing for long periods of time. 4. Repetitive lifting, kneeling, and bending with packages in excess of 50 lbs. is required. 5. Production demands may require overtime and/or evening or weekend scheduling. Compensation $23.00 per hour non-exempt Recipe for Success Reser’s is the leading provider of fresh refrigerated deli salads, side dishes, and prepared foods for the supermarket, club store, and food service industries. Family owned and operated, Reser’s has been a proud sponsor of good times at racetracks, picnics, BBQs, music festivals, and affordable family meals since 1950. Reser’s family of brands include Reser’s American Classics, Main St Bistro, Stonemill Kitchens, and more. With more than 4,500 employees, Reser’s operates 14 facilities in the US, Mexico, and Canada and actively supports the communities it serves. 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.
REVA is seeking a detail-oriented Quality Systems Engineer to support and maintain the company's Quality Management System while also serving as the hands-on administrator of the current electronic Quality Management System (eQMS) and leading the selection and implementation of a new enterprise eQMS platform. This role blends day-to-day quality system execution - documentation, CAPA support, and audit readiness - with ownership of the technical administration and project management needed to keep the company's digital quality infrastructure compliant, reliable, and positioned for growth. This position is well suited for a professional who combines strong quality system execution skills with hands-on systems administration ability and the project management discipline to lead a multi-phase software selection and implementation effort from requirements through go-live. Key Responsibilities: Quality System Support Support the maintenance and execution of the ISO 13485/FDA Part 820 QSMR/Part 4 device-led combination product Quality Management System. Execute assigned quality system activities in accordance with established procedures. Assist in preparation for internal, external, customer, and supplier audits. Track audit findings and support closure of corrective actions as directed. eQMS Administration Serve as the hands-on system administrator and business process owner for the company's current electronic quality system based on Salesforce platform, including configuration, maintenance, and support of workflows, forms, records, permissions, dashboards, and related functionality for processes such as Nonconformance, CAPA, Change Control, training, document control, and complaints. Partner with internal stakeholders and external vendors to translate business and compliance needs into system requirements and configuration changes, including managing vendor support for changes beyond administrator-level permissions. Develop, revise, and maintain SOPs, work instructions, and training materials associated with electronic quality system processes. Coordinate and/or execute user acceptance testing, validation support activities, defect tracking, and implementation documentation in accordance with company procedures and regulatory expectations. Provide end-user support and training to improve adoption, data quality, and compliant use of electronic systems. Identify and recommend process and system improvement opportunities based on user feedback, audit observations, and operational needs. eQMS Selection and Implementation Own day-to-day execution of the company's eQMS selection and implementation initiative, from requirements gathering through solution evaluation, implementation planning, rollout, and post-go-live stabilization. Partner with Quality leadership to evaluate eQMS options, compare vendor capabilities, coordinate demonstrations, support business case development, and contribute to vendor selection and procurement decisions. Define and document user requirements, future-state process needs, functional gaps, implementation priorities, and risks for leadership review. Develop and maintain the project plan, timeline, decision log, action-item tracker, status reports, and risk/issue register for the eQMS program. Coordinate cross-functional project teams and workstreams to align scope, resources, timelines, data migration needs, training plans, and change management activities. Communicate project status, key decisions, dependencies, and risks to stakeholders, including Quality leadership. Prepare agendas, facilitate working sessions, document outcomes, and drive completion of assigned deliverables. DocumentationChange Control Maintain controlled documents, records, and training documentation within the QMS as part of QA team. Support document revisions, change requests, and record updates. Ensure documentation accuracy and compliance with quality system requirements. CAPANonconformance Support Support root cause analysis and corrective and preventive action (CAPA) activities. Track CAPA progress and verify completion and effectiveness under supervision. Assist with investigation and documentation of nonconformances and deviations. Project Coordination Assist with coordination of assigned, limited-scope projects related to quality, manufacturing, or compliance. Track action items, timelines, and deliverables for assigned initiatives. Prepare status updates and communicate progress or risks to project owners or functional leads. Support handoff and knowledge transfer activities as part of transition planning. Cross-Functional Coordination Coordinate with engineering, manufacturing, and supply chain teams to ensure quality requirements are followed. Support quality-related activities for product development and manufacturing operations. Provide routine status updates on assigned tasks and projects. MetricsReporting Collect and organize quality system metrics and project tracking data. Maintain logs, trackers, and reports for audits, CAPAs, training, and assigned projects. What We Look For Strong knowledge of FDA 21 CFR 820, 210/211, Part 4 combination products, and ISO 13485 requirements. Deep knowledge of quality assurance terminology, methods and tools Excellent analytical, problem-solving and decision-making skills. Demonstrated knowledge of quality best practices, version-control procedures and defect management processes. Superb computer proficiency, including database management. Bachelor's degree (or equivalent) in engineering or related field Understanding of agile/scrum methodology and how QA functions within it. Ability to communicate in more than one language REVA is an equal opportunity employer. All qualified applicants will receive consideration for employment at REVA without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, REVA will not sponsor applicants for U.S. work visa status for this opportunity.
Job Summary Join our dynamic manufacturing team as a Manufacturing Associate I, where your energy and attention to detail will drive the production and packaging of high-quality diagnostic products. This position is responsible for manual and semi-automated assembly, quality inspection, packaging, and documentation—executed in strict alignment with standard operating procedures (SOPs) and quality standards. The role directly contributes to maintaining high product quality, cleanliness, safety, and operational efficiency across production environments. This position offers an exciting opportunity to develop foundational skills in medical device manufacturing while contributing to life-changing products. Duties Assembly & Manufacturing * Assemble units and components following detailed work instructions and SOPs. * Operate manual and semi-automated assembly equipment. * Load and unload materials, inspecting components for visible defects. * Support equipment start-up, shut-down, and perform basic sanitation tasks. * Maintain line clearance to prevent product or lot mix-ups. * Assist machine operators in monitoring equipment and reporting malfunctions. * Recommend process improvements to enhance product quality and efficiency. * Conduct in-process quality inspections during assembly and packaging. * Accurately document production and environmental conditions per Good Documentation Practices (GDP). * Verify availability of necessary materials and calibrated equipment before starting work. * Immediately escalate unresolved quality or safety concerns to management. Packaging & Fulfillment * Assist with order fulfillment, including picking, packing, labeling, and shipping. * Follow established packaging procedures to ensure product integrity during transport. * Adhere to work instructions for proper packaging specifications. Workplace Safety & Maintenance * Maintain a clean, organized, and safe work environment. * Comply with PPE guidelines and cleanroom gowning protocols. * Follow all safety policies and contribute to a culture of continuous improvement and quality. Experience * Prior experience in a manufacturing environment preferred * Experience in cleanroom / dry room or controlled environment settings preferred * Mechanical knowledge or experience with machining or equipment maintenance is advantageous Join us to be part of a vibrant team committed to producing safe, effective products that make a difference. We foster a culture of safety, continuous learning, and innovation—empowering you to grow your skills while contributing to meaningful work! Pay: $18.00 - $23.00 per hour Benefits: * Dental insurance * Health insurance * Life insurance * Paid time off * Retirement plan * Vision insurance People with a criminal record are encouraged to apply Work Location: In person
Scope of the Role As Manager, Quality Engineer (Contract), you’ll lead quality engineering execution and provide hands-on technical direction to support compliance, risk remediation, new product development, and operational effectiveness. This onsite role in San Diego (5751 Copley Drive) is designed to strengthen product safety, reliability, and documentation rigor across programs. Key responsibilities include leading and coaching Quality Engineers; driving risk-based problem solving and continuous improvement; supporting design and sustaining activities to applicable quality/regulatory standards; overseeing investigations and CAPA; partnering with suppliers on critical issues (including occasional onsite support); and developing/approving validation and test activities (IQ/OQ/PQ, method qualification/validation, gauge R&R, calibration procedures, and statistically sound sampling plans). You’ll also review/approve controlled documents and contribute to Management Review inputs. Required qualifications: - BS in an engineering discipline - 5–7+ years in medical devices or similarly regulated ISO/cGMP/GLP environments - Catheter/medical device experience; interventional cardiology helpful - Complaint/CAPA investigation experience; strong statistics (DOE/Six Sigma) and root-cause skills - Validation/compliance track record (e-beam sterilization and software validation preferred) Apply to be considered for this contract opportunity. How Your Days Flow You’ll start onsite by aligning priorities with cross-functional partners, then shift between focused desk work and quick, in-person touchpoints with engineers and operations. Expect time in documents and data—reviewing technical reports, checking traceability, and ensuring controlled records are ready for review. Midday often includes short working sessions to unblock decisions, followed by time to shape clear recommendations for stakeholders. As the day progresses, you’ll balance mentoring conversations with crisp status updates, keeping communication practical and action-oriented. When supplier or product issues arise, you’ll coordinate next steps and confirm timelines, closing out the day by organizing deliverables for upcoming reviews and keeping the team’s quality metrics moving in the right direction.