Staff Quality Engineer, Medical Device QMS Lead

PETcoil; Sunnyvale (CA); On-site; USD 145,000 - 195,000; Full time

Benefits offered by this job

Stock options

Medical, dental, and vision plans

401(k) retirement savings plan

Job summary

PETcoil, a clinical-stage health technology startup, seeks a Staff Quality Engineer to build and maintain a scalable QMS and lead quality activities across design controls, risk management, audits, V&V, supplier quality, and manufacturing. You will partner with cross-functional teams to ensure audit-ready quality systems and successful commercialization.

The role requires 8+ years in medical device quality, strong knowledge of FDA QMSR, ISO 13485, and GDP, and excellent communication to

Qualifications

• Experience implementing a QMS at a medical device startup (<50 employees).
• 8+ years in quality assurance/engineering in medical devices.
• Strong knowledge of FDA 21 CFR Part 820 / QMSR, ISO 13485, ISO 14971, IEC 60601, IEC 62304, GDP.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Own the QMS oversight, ensuring audit-ready processes and documentation.
• Lead design controls, risk management, and V&V activities.
• Manage supplier quality, inspections, and release criteria.
• Coordinate internal and external audits and management reviews.
• Provide quality training and guidance to cross-functional teams.

Skills

QMS leadership

Regulatory knowledge

Audits

Risk management

V&V

GDP

Education

Bachelor's degree in engineering

Job description

PETcoil, a clinical-stage health technology startup, seeks a Staff Quality Engineer to build and maintain a scalable QMS and lead quality activities across design controls, risk management, audits, V&V, supplier quality, and manufacturing. You will partner with cross-functional teams to ensure audit-ready quality systems and successful commercialization.

The role requires 8+ years in medical device quality, strong knowledge of FDA QMSR, ISO 13485, and GDP, and excellent communication to