Product Complaint Specialist II

Job description

POSITION SUMMARY: The Product Complaint Specialist is responsible for ensuring all customer complaints and feedback for products and services are adequately documented and managed in accordance with internal procedures, ISO 9001 and 13485 standards, and applicable regulatory requirements. This role is also responsible for the management of the Field Action process from initial assessment through closure. DUTIES AND RESPONSIBILITIES: - Review complaint records for completeness and accuracy prior to closure and collaborate with internal teams to collect any missing required information. - Review complaint investigations, including root cause analysis, for adequacy. - Collaborate with cross-functional teams to drive timely completion of investigations and related activities. - Assess the need for Corrective and Preventive Actions (CAPA) as a result of complaints. - Participate in Material Review Board meetings to review and approve product dispositions and recommend the need for Field Actions. - Manage Field Actions from initiation to closure, including drafting customer notifications, routing documentation for approvals, and executing notification campaigns. - Generate, analyze, and...