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. Base Pay Range $180,000.00/yr - $210,000.00/yr Additional Compensation Annual Bonus and Stock options Company & Product Info 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. Funding & Status 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. The Role 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. What You’ll Own 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 What We’re Looking For 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 Why Join 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 Benefits Medical insurance 401(k) Vision insurance Other Information No H1B or Visa Transfers — must have US Work Authorization or be a US Citizen. Local Candidates strongly preferred. Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Engineering and Quality Assurance #J-18808-Ljbffr Cambridge Recruiters