Product Quality Engineer
Listed on 2026-02-12
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Engineering
Biomedical Engineer, Quality Engineering, Medical Device Industry
This range is provided by Bio Talent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range$/yr - $/yr
Sr. Recruitment Consultant - Medical Device | QA/RA | SaMD | SF Bay AreaA fast-growing medical device company focused on pre-market Class II/III products is seeking a Product Quality Engineer to support the development and regulatory approval of innovative medical technologies. This role will play a critical part in ensuring design, development, and risk management activities meet regulatory and quality standards before market approval.
Key Responsibilities:
- Provide quality engineering support throughout the product development lifecycle, ensuring compliance with FDA 21 CFR 820, ISO 13485, and ISO 14971.
- Work closely with R&D and Regulatory teams to develop design controls, risk management files, and verification/validation plans.
- Support the creation and execution of design verification and validation (V&V) testing.
- Assist in developing product and process risk assessments (FMEAs).
- Ensure compliance with Good Documentation Practices (GDP) and participate in internal audits and regulatory submissions.
- Collaborate with suppliers and manufacturing partners to establish incoming quality requirements for components and materials.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- 3+ years of quality engineering experience in the medical device industry, preferably with pre-market products.
- Strong understanding of design control, risk management, and V&V testing.
- Experience with ISO 13485, FDA regulations, and product development processes.
- Knowledge of biocompatibility, sterilization validation, and usability engineering is a plus.
This is an exciting opportunity to be at the forefront of developing innovative medical technologies before they reach the market. If you're passionate about quality engineering in early-stage medical devices, apply today!
Seniority levelMid-Senior level
Employment typeFull-time
Job functionQuality Assurance, Engineering, and Design
IndustriesStaffing and Recruiting, Medical Equipment Manufacturing, and Biotechnology Research
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