This position ensures robust governance and execution of post-market quality processes including CAPA management and issue impact determinations
Job Summary
This position ensures robust governance and execution of post-market quality processes including CAPA management and issue impact determinations.
The role partners cross-functionally to scope field actions, facilitates Health Hazard Evaluations, and delivers data-driven insights for decision-making.
Candidates must have a proven track record of compliance excellence with direct communication experience with the FDA.
Matching Summary
This position 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 rewards and recognition programs
Skills & Requirements
Must-have
7 years medical device QA experience
ISO 14971 risk management expertise
FDA regulatory correspondence management
CAPA investigation and verification
Field action committee facilitation
Nice-to-have
Cross-functional leadership capabilities
Data analytics for KPI monitoring
Continuous improvement drive
Strong problem-solving skills
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
Comprehensive knowledge of ISO 13485, ISO 9001, 21 CFR Part 820, and EU MDR