Sr Quality Engineer

Senior Quality Engineer (Medical Device)

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 Med Tech companies through commercial stage, so this is an exciting time to join.

• 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.

• 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.