This role ensures robust governance and execution of post-market quality processes including CAPA management and issue impact determinations
Job Summary
This role ensures robust governance and execution of post-market quality processes including CAPA management and issue impact determinations.
The position requires evaluating quality signals to determine escalation and aligning investigations with regulatory requirements while partnering cross-functionally.
Candidates will drive continuous improvement across the quality system and leverage analytics to monitor KPIs and identify systemic issues.
Matching Summary
This role ensures robust governance and execution of post-market quality processes including CAPA management and issue impact determinations.
Salary
Base: $155,900.00 - $257,300.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive package including well-being and development rewards
Skills & Requirements
Must-have
7 years medical device QA experience
ISO 14971 risk management expertise
FDA regulatory response drafting
CAPA investigation and verification
Health Hazard Evaluation facilitation
Nice-to-have
Cross-functional collaboration skills
Data analytics for KPI monitoring
Continuous improvement leadership
Strategic decision-making abilities
Key Requirements
Bachelor's Degree in Engineering or Life Sciences
Minimum 7 years progressive experience in medical device Quality Assurance
Minimum 5 years hands-on risk management expertise
Direct communication experience with FDA
Knowledge of ISO 13485, ISO 9001, 21 CFR Part 820, and EU MDR