"ISO 13485" jobs

Pleasanton, California

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Today

Key Responsibilities: Design and develop automation frameworks using TypeScript, JavaScript, Node.js.Implement UI automation using Playwright and Cypress.Build and maintain API automation solutions.Integrate automation suites with test management tools.Collaborate with developers and QA teams to ensure BDD practices using Cucumber.Set up and maintain CI/CD pipelines for automated test execution.Participate in code reviews and contribute to best practices for test automation.Troubleshoot and opti

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Contract, Third Party

$60 - $65

Product Transfer Manufacturing Engineer (24 month contract)

Arroyo

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Today

Work Flexibility: Onsite What you will do: Support the design and testing of new products.Ensure that everything functions well and meets quality standards.Identify and prevent potential problems (especially risks, defects, and inspection issues).Ensure the product can be manufactured efficiently and safely.Support validations (process, tool, and equipment testing) What you will need: Required: University degree in engineering (or similar).Experience in regulated industries, such as medical d

Full-time

Ingeniero Sr Procesos

Nuevo Laredo, Tamaulipas

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Today

Job Description Objetivo General: Define y establece los procedimientos relacionados al proceso para la fabricacin de productos, cumpliendo con las especificaciones de calidad de la manera ms eficiente de acuerdo con los objetivos de la compaa. Responsable en el desarrollo, ejecucin de proyectos y actividades alineando las estrategias de la compaa, para la mejora y/o control de los procesos, as como de los mtricos relevantes de eficiencia, calidad y costo de la planta a travs de anlisis, metod

Full-time

Single Use Technology Audit Lead, Quality Systems

Logan, Utah

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Office Job Description At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making s

Full-time

Product Certification Safety- EE Contractor

Lake Forest, California

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Today

Location: Lake Forest, CA Salary: $50.00 USD Hourly - $75.00 USD Hourly Description: Minimum Qualifications Education: Bachelor's degree in Electrical Engineering or related field.Experience: 4+ years in medical device product safety compliance evaluations or experience in fully accredited test labs (e.g., UL, CSA, Intertek, Element).Expertise: Deep knowledge of IEC 60601-1 3rd Edition (including 3.1 and 3.2), collateral and particular standards for medical electrical equipment.Collaboration

Contract

USD 50.00 - 75.00 per hour

Automation Engineer

Indianola, Pennsylvania

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8d ago

Are you interested in working with the World s leading AI-powered Quality Engineering Company? Ready to advance your career, team up with global thought leaders across industries and make a difference every day? Join us at Qualitest! We are looking for an Automation Engineer to join our growing team in Indianola, PA United States! Skill & Competency Requirements: Bachelor s degree in Engineering, preferably Computer, Electronics, Electrical.Minimum of 5 years or more experience in automated test

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Full-time

$70,000 - $90,000

Supplier Quality Engineer

East Hanover, New Jersey

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Today

Supplier Quality Engineer Needed For Leading Contract Manufacturer This Jobot Job is hosted by: Kevin Finlay Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $100,000 - $120,000 per year A bit about us: My client is a leading contract manufacturer and is growing! They are looking to add a Quality Engineer focused on supplier quality to their team. In this role you will be responsible for managing supplier quality activities, developing and m

Full-time

USD 100,000.00 - 120,000.00 per year

Regulatory Affairs Specialist Consultant

Newton, Massachusetts

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Today

Location: Newton, MA Salary: $65.00 USD Hourly - $87.00 USD Hourly Description: Our client is currently seeking a Regulatory Affairs Specialist Consultant for a 12 month + contract. As a Regulatory Affairs Specialist Consultant you will be responsible for: Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US market as well as markets outside of the US (e.g. Europe, Asia). In collaboration with subject matter experts, independen

Contract

USD 65.00 - 87.00 per hour

Product Safety Engineer / Lab Setting / Irvine, CA

Irvine, California

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Today

Our client, based in South Orange County, is one of the leading medical device manufacturers in the optical surgery industry. They are urgently seeking a Laboratory Safety Engineer to work hands-on with their medical devices in the lab. The company continues to expand, adding new engineers to their teams each month. This role is hybrid with four days onsite per week, so candidates must be local to the South Orange County area. Required Qualifications Education & Experience: BS degree with 3+ y

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Full-time

USD 65.00 - 70.00 per hour

Senior Engineer, Quality Assurance

Washington

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Today

Work Flexibility: Hybrid Senior Engineer, Quality Assurance Redmond, WA Join a team where your expertise directly impacts patient safety and product performance. As a Senior Quality Assurance Engineer, you'll lead critical investigations and drive improvements that shape the future of medical technology. This is a high-impact role for someone passionate about solving complex problems and ensuring quality excellence across the product lifecycle. Work Flexibility: Hybrid: Candidates must resid

Full-time

USD 88,800.00 - 142,300.00 per year

Medical Device Electrical Safety Engineer | Lake Forest, California | Onsite

Lake Forest, California

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Today

Title: Medical Device Electrical Safety Engineer Location: Lake Forest, California | Onsite Duration: 6-12+ Months Role Requirements: Minimum Education and Experience: BS + 2 years in medical device products safety/EMC compliance, and/or fully-accredited test labs such as UL, CSA, Intertek or Element, etc. Proven experience in successfully being able to work cross functional teams EMC/60601-1 experience with Medical Devices is a MUST Core responsibilities: Perform Safety, EMC and Wireless tes

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Contract, Third Party

Manufacturing Tooling Engineer

Raynham, Massachusetts

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2d ago

Looking for a mechanical/manufacturing engineer Experience with process validation required Experience with GD&T, CMM, gaging required Experience with statistical analysis/Minitab preferred Experience with CAD, NX preferred Experience with Windchill preferred Experience with fixture/gage design is a plus Wax injection tooling/injection molding experience is a plus Foundry experience is a plus Required Qualifications Education: Bachelors degree in mechanical engineering, Manufacturing E

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Third Party, Contract

40 - 45

Manufacturing Validation Engineer with CNC

Warsaw, Indiana

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2d ago

Role: Validate CNC equipment and related processes used to manufacture medical devices.Focus: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment.Aim: Ensure robust, reproducible manufacturing processes and maintain inspection-ready documentation.Key Responsibilities Develop and execute validation activities for CNC machines (e.g., mills, lathes, multi-axis CNCs) and associated tooling/work holding.Create and maintain validation do

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Contract, Third Party

40 - 45

Packaging Validation Engineer

Bloomington, Indiana

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2d ago

Recent 4-6 years experience in Packaging Validation activities - Hands on experience in packaging validation activities, including packaging integrity, shelf life, and transit testing. - Prepare packaging verification protocols and reports in compliance with regulatory and internal requirements. - Hands-on experience in Process validation (IQ, OQ & PQ) activities. - Lead or support complaint investigations and resolution related to packaging. - Support engineering in product validation, risk ass

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Contract, Third Party

40 - 45

Supplier Quality Engineer

Mounds View, Minnesota

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2d ago

We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier qualification, PPAP documentation, and process validation. This role is critical in ensuring that suppliers meet Medtronics quality standards and regulatory requirements. Key Responsibilities: Supplier Qualification & Management:Qualify suppliers in accordance with company standar

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Contract, Third Party

45 - 50

Senior Validation Engineer

Buffalo Grove, Illinois

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Today

Job Posting Start Date 12-10-2025 Job Posting End Date 02-27-2026 Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraord

Full-time

USD 74,800.00 - 102,900.00 per year

Senior QMS Process Engineer

Remote or New Jersey

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Today

Responsibilities: Draft, update, and optimize QMS procedures to align with Code beamer upgrades, organizational standards, and regulatory requirements. Collaborate with cross-functional Quality and R&D teams to ensure procedures accurately reflect best practices and compliance expectations. Translate technical and regulatory requirements into clear, practical documentation for end users. Support change management processes, ensuring procedural updates are properly controlled and communicated. En

Full-time

Development Mechanical Engineer

Broadview Heights, Ohio

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Today

Summary Proficiency in CAD (SolidWorksPTC Creo), GDT, tolerance analysis, and fixture design. Strong capability in test protocol report writing, statistical analysis (9595, tolerance intervals), and data integrity practices. Familiarity with materials and processes Ti alloys, CoCr, stainless steel, UHMWPE, PEEK, AM, coatings. Understanding of design controls, ISO 13485, ISO 14971, and regulatory pathways (510(k), PMA, MDR). Competence in risk management tools (DFMEA, pFMEA) and traceability from

Full-time

R&D /Product Development Engineer

Cleveland, Ohio

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Today

Roles & Responsibilities: Proficiency in CAD (SolidWorks/Creo). GD&T tolerance analysts, and fixture design. Knowledge of orthopedic testing standards (ASTM F382 F543, F1717. F2/14243, etc.). Strong capability in test protocol/report writing statistical analysis (95/95, tolerance intervals), and data integrity practices. Familiarity with materials and processes: Ti alloys. Coctainless steel UHMWPE, PEEK. AM. coatings. Understanding of design controls ISO 13485, ISO 14971, and regulatory pat

Full-time

Validation engineer

Broadview Heights, Ohio

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Today

Summary : Supports testing and validation activities for medical devices, ensuring compliance with regulatory and quality standards. Roles & Responsibilities : Prepare test samples and fixtures for mechanical and functional testing. Execute tests and document results per Good Documentation Practices (GDP).Generate Test Reports for inclusion in the Design History File (DHF). Coordinate with cross-functional teams to ensure timely completion of testing activities. Education & Experience : Hands-on

Full-time

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