- Capstan Medical
- Santa Cruz, CA
- Full-Time
- 88 days ago
Quality Engineer, Heart Valve Product Quality.
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Quality Engineer, Heart Valve Product Quality: our view in 3 lines...
- The Role:This role is for a quality engineer supporting structural heart valve products in a regulated medical device setting.
- The Person:The person will support design controls, risk management, sterilization activities, microbiology test methods, manufacturing acceptance work, NCR, MRB, CAPA, audits, continuous improvement, and SOP and quality record updates.
- Requirements:The ideal candidate has a bachelor's degree in Engineering, Life Sciences, Microbiology, or a related technical field, plus 5+ years of quality engineering experience and familiarity with FDA 21 CFR Part 820, QMSR, ISO 13485, ISO 14971, and ISO 5840.
About the role
At Capstan Medical, we’re building one of the most exciting and innovative companies in medtech—developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. Our team combines surgical robotics, catheter-based delivery, and next-generation implants to transform complex procedures into safer, lower-stress solutions for patients and clinicians alike. As a highly collaborative, hands-on team, we move fast, wear multiple hats, and believe the best ideas can come from anyone.
Based in Santa Cruz, our unique workspace blends cutting-edge Bay Area innovation with a lifestyle-driven environment near trails, beaches, and open space—creating the perfect place to do meaningful, career-defining work.
