Post Market Surveillance Manager

Post-Market Surveillance Manager

Fulltime opportunity for a Post-Market Surveillance Manager.

This person will 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 for products and ensure effective execution into the Quality Management System (QMS).

This position is responsible for initiating and supporting quality systems activities in all aspects of the business, including the identification and implementation of continuous process improvement activities.

Maintain oversight, tracking, and escalation for Post Market Processes and take action to ensure processes are maintained per company policies and industry standards.

Qualifications

• Bachelor's Degree (BA) from a four-year College or University in a technical, engineering, and/or scientific discipline; Master or terminal science degree preferred.
• Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g., CQM, ASQ, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles).
• 6+ years experience in a regulated Medical Device or Life Sciences industry with applied experience/knowledge in Investigations, Root Cause Analysis, Complaint Handling, Statistical Analysis, Risk Management, Design Control, Process Validation, FMEA/Risk Assessment, and ISO/QSR;
• At least 1-2 years of Supervisory or Management experience.