Position Details
About this role
Senior quality engineer for medical device combination product development with emphasis on design controls, risk management, and regulatory compliance. Partners with device engineering to ensure product quality and lifecycle oversight across development and manufacturing.
Key Responsibilities
- Lead quality engineering for combination product programs
- Align with device engineering on verification, validation, and tech transfer
- Ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971
- Plan and track quality initiatives
- Develop and approve controlled documentation (protocols, plans, reports, risk analyses, specs, test methods)
Technical Overview
Regulatory-focused quality engineering for combination products; knowledge of FDA/ISO requirements, DHF/RMF, and design transfer processes; strong documentation, testing, and cross-functional collaboration.
Ideal Candidate
The ideal candidate is a senior quality engineer with 6+ years of QA experience in medical devices and combination products, with strong design controls, risk management, and regulatory knowledge (FDA/ISO). They demonstrate capability to lead cross-functional quality activities and deliver compliant documentation (DHF/RMF).
Must-Have Skills
Nice-to-Have Skills
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of degree in engineering or related field, No experience in medical device QA or combination products, No knowledge of FDA 21 CFR Part 820 or ISO 13485/14971
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