Post Market Surveillance Manager
On-site · Clearwater, Florida, United States
Job Summary
Lead the development, governance, and integration of Customer Complaints, Medical Device Reporting, Adverse Event Reporting, Corrections and Removals (Recall), and proactive Post Market Surveillance processes, ensuring effective execution within the Quality Management System (QMS). Oversee quality systems activities and drive continuous process improvement. Maintain oversight, tracking, and escalation for post-market processes per company policies and industry standards. Requires 6+ years in a regulated Medical Device/Life Sciences environment with investigations, root cause analysis, complaint handling, statistical analysis, risk management, design control, process validation, FMEA/risk assessment, and ISO/QSR knowledge; plus 1-2 years of supervisory/management experience.
Required Qualifications
- Bachelor’s Degree in technical, engineering, or scientific discipline
- Master or terminal science degree preferred
- 6+ years experience in a regulated Medical Device or Life Sciences industry
- Experience in Investigations, Root Cause Analysis, Complaint Handling, Statistical Analysis, Risk Management, Design Control, Process Validation, FMEA/Risk Assessment, ISO/QSR
- At least 1-2 years of Supervisory or Management experience
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