Sr Quality Engineer
Senior Quality Engineer (Medical Device)
Salary: $140,000 - $170,000
California
We're partnered with a commercial-stage cardiovascular medical device company that is building out their Quality leadership team in California. While an exciting opportunity from a growth standpoint, they also strike a balance of stability since they're already revenue-generating. This leadership team has a proven track record of scaling MedTech companies through commercial stage, so this is an exciting time to join.
Responsibilities
- Lead quality engineering activities for new and commercial cardiovascular products, ensuring compliance with FDA, ISO 13485, and applicable regulatory standards.
- Drive root cause investigations, nonconformance management, and CAPA execution with strong cross‑functional collaboration.
- Implement and optimize process controls, risk management (per ISO 14971), and quality system improvements across manufacturing and supplier operations.
- Support design changes, validation activities, and post‑market surveillance to maintain product performance and patient safety.
Qualifications
- Bachelor's degree in engineering or related field; advanced degree preferred.
- 5+ years of quality engineering experience in medical devices, ideally in Class III or cardiovascular technologies.
- Strong working knowledge of quality systems, risk management, statistics, process validation, and design controls.
- Demonstrated experience leading investigations, driving CAPA to closure, and collaborating effectively with technical and manufacturing teams.
Apply now if you are interested!
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