Lead QA Engineer - Medical Devices, Class III

Cambridge Recruiters; San Carlos (CA); Sur place; USD 180 000 - 210 000; Plein temps

Avantages offerts par ce poste

Medical insurance

401(k)

Vision insurance

Résumé du poste

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.

Responsabilités

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

Connaissances

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

Description du poste

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.