Quality Assurance Manager

This range is provided by Cambridge Recruiters. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

Annual Bonus and Stock options

Well-funded medical device startup (~5 people) developing a Class III Active Implantable cardiac diagnostic system for heart failure. The platform includes a catheter-based delivery system and a Nitinol implant with integrated sensors and electronics.

Recently closed $20MM Series B strategic financing from an established medical device company. Recent hires include two proven medical device professionals from a well-known local medical device incubator, adding deep experience in implantables, clinical execution, and regulatory strategy. The team is now focused on growing the team to support ongoing development, V&V testing, and progressing toward a First-in-Human clinical study.

We’re seeking a hands‑on Quality & Design Assurance Lead to own our QMS and Design Quality. The position may be filled by a Quality Manager or a seasoned contributor (Staff or Principal QE) stepping into a true leadership role at a startup while remaining deeply involved in execution.

• End‑to‑end ownership of an ISO 13485 / 21 CFR 820 QMS
• Internal and external audits, CAPA, NCRs, Supplier Quality, and documentation
• Design Controls, Design Verification & Validation, Risk Management (ISO 14971), and FMEAs
• Design Quality for implantable electronics, sensors, Nitinol implants, and catheter delivery systems
• Quality oversight for sterilization, biocompatibility, packaging, and labeling
• Inspection readiness for FDA and strategic partner audits

• 8–12+ years of Quality experience in medical devices
• Experience with Class III, PMA, AIMD, implantables, and/or catheter‑based systems
• Strong hands‑on ownership of both QMS and Design Quality
• Comfortable working in a small, fast‑moving startup environment
• Motivated to grow into a broader leadership role as the company scales

• Own Quality for a Class III Active Implantable cardiac system
• Strong financial backing, long runway, and experienced senior leadership
• High visibility, autonomy, and real impact on a first‑in‑class technology

• Medical insurance
• 401(k)
• Vision insurance

No H1B or Visa Transfers — must have US Work Authorization or be a US Citizen.

Local Candidates strongly preferred.

Mid‑Senior level

Full‑time

Engineering and Quality Assurance