Quality Assurance Manager

Cambridge Recruiters; San Carlos (CA); On-site; USD 180,000 - 210,000; Full time

Benefits offered by this job

Medical insurance

401(k)

Vision insurance

Job summary

A medical device startup is seeking a Quality & Design Assurance Lead to manage their QMS and oversee quality for a Class III cardiac diagnostic system. The ideal candidate will have 8–12 years of experience in medical devices, particularly in implantables and catheter-based systems. This role offers an opportunity for significant impact in a fast-paced environment with strong financial backing and leadership support.

Qualifications

• 8–12+ years of Quality experience in medical devices.
• Strong hands-on ownership of both QMS and Design Quality.
• Comfortable working in a small, fast-moving startup environment.

Responsibilities

• Own ISO 13485/21 CFR 820 QMS.
• Conduct internal and external audits.
• Manage design verification and validation, risk management.

Skills

Quality experience in medical devices

End-to-end ownership of QMS

Experience with Class III and implantables

Ability to work in a fast-moving startup

Strong hands-on skills in Design Quality

Job description

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