This position is responsible for leading the end-to-end process related to product quality issue escalations through risk management frameworks
Job Summary
This position is responsible for leading the end-to-end process related to product quality issue escalations through risk management frameworks.
The role requires coordinating recall strategy plans and managing all field action activities to ensure successful completion per established strategies.
Candidates must possess strong communication skills to prepare executive briefings and facilitate determinations at Risk Management and Quality Review Boards.
Matching Summary
This position is responsible for leading the end-to-end process related to product quality issue escalations through risk management frameworks.
Skills & Requirements
Must-have
End-to-end escalation process management
Risk Management Board presentation skills
Field action coordination and execution
FDA and ISO regulatory compliance knowledge
Cross-functional stakeholder collaboration
Nice-to-have
ASQ certification (CQE, CQM, CRE, or CQA)
Experience with capital systems instrumentation
Background in post-market surveillance
Audit preparation and subject matter expertise
Continuous improvement project leadership
Key Requirements
Bachelor's degree in scientific or engineering discipline
Minimum of 6 years of related work experience
Experience in medical device or pharmaceutical industry preferred