Responsibilities
- Leads the complaint evaluation team to ensure accurate, timely risk assessments and complete investigation processes.
- Oversees product-specific systems and documentation to support a compliant complaint management process aligned with FDA, ISO, and global regulations.
- Identifies and escalates reportable complaints or inquiries, coordinates cross-functional communication, and ensures completion of the post-market Risk Analysis Worksheet (RAW).
- Provides regular updates on escalated issues, key priorities, and complaint statuses to management and leadership teams.
- Leads RAW team meetings, offering direction and decision-making support.
- Coaches and develops team members to effectively carry out their assigned functions.
- Organizes monthly cross-departmental complaint trend reviews and ensures appropriate actions—including escalations, investigations, and CAPA—are implemented to address recurring issues or specific customer concerns, including root cause identification.
- Supplies complaint data for inclusion in post-market surveillance reporting.
- Maintains and reports on complaint-related KPIs as required.
- Collects and analyzes complaint and RAW data for post-market surveillance activities, including updates to risk assessments and identification of new risks.
- Ensures compliance with all applicable regulatory standards in complaint handling.
- Develops and manages a system for monitoring literature and social media sources for potential complaints.
- Oversees tasks related to complaint investigations, including management of returned materials and external vendor assignments.
- Supports technical investigations and advises on solutions for product malfunctions.
- Completes additional duties as directed by management.
Benefits
- Eligible for medical, dental, and vision insurance, 401k plan with employer match, paid vacation, and sick leave.
- Sales positions qualify for commission plans; management and select professional roles may receive performance-based bonuses.
