Product Complaint Specialist I

Job description

POSITION SUMMARY: The Product Complaint Specialist I 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. DUTIES AND RESPONSIBILITIES: - Assist in reviewing complaint records for completeness and accuracy prior to closure and collaborate with internal teams to ensure all required information is collected. - Assist in reviewing 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. - Generate, analyze, and report quality metrics to assess Quality Management System (QMS) performance and identify opportunities for improvement. - Assist with quality-related documentation (e.g., procedures, reports, assessments) related to complaint case management processes. - Assist during internal and external audi...