Engineering Manager, Post Market Quality
Core
Lead global post-market quality systems, failure analysis, complaint handling, and regulatory reporting for medical devices.
Role type
Engineering Manager, Post Market Quality
Builds
Post-market quality processes, complaint handling workflows, and regulatory reporting systems
Domain
Medical Devices / Regulatory Quality
Required skills
Post-market quality management, failure analysis, complaint handling, regulatory reporting (MDR/MDV), team leadership, cross-functional partnership, data analysis, continuous improvement, budget management
Preferred skills
Master's degree, Certified Quality Engineer/Auditor, advanced Excel, statistical analysis (Minitab), database management
Technologies
Microsoft Office Suite, Minitab
Responsibilities
Provide strategic leadership for post-market quality systems; lead and develop a team of quality engineers; oversee end-to-end complaint handling and regulatory reporting; establish quality objectives and monitor key metrics; interpret global post-market requirements and assess compliance risks; partner with cross-functional leaders to resolve quality issues; lead complaint trending and data analysis; represent the function during audits and regulatory interactions; drive continuous improvement of post-market processes; manage resources and budget for the Complaint Handling organization
Seniority
Manager, hands-on leadership