This position ensures robust governance and execution of post-market quality processes, including CAPA management, issue impact determinations, field action decisions and follow-ups
Job Summary
This position ensures robust governance and execution of post-market quality processes, including CAPA management, issue impact determinations, field action decisions and follow-ups.
The role evaluates quality signals to determine escalation, aligns investigations and corrective actions with regulatory requirements, and partners cross-functionally to scope field actions.
It manages regulatory communications such as FDA responses, drives continuous improvement across the quality system, and leverages analytics to monitor KPIs, identify systemic issues, and implement timely, validated solutions.
Matching Summary
This position ensures robust governance and execution of post-market quality processes, including CAPA management, issue impact determinations, field action decisions and follow-ups.
Salary
$155,900.00 - $257,300.00 USD Annual
Skills & Requirements
Must-have
CAPA management
issue impact determinations
field action decisions
regulatory requirements
risk management expertise
ISO 14971 principles
Nice-to-have
continuous improvement
data-driven insights
cross-functional collaboration
product safety
customer trust
Key Requirements
Bachelor’s Degree in Engineering, Life Sciences, or related technical discipline
Minimum 7 years of progressive experience in medical device Quality Assurance
Minimum 5 years of hands-on risk management expertise
Demonstrated experience in direct communication with FDA
Comprehensive knowledge of global quality and regulatory standards