About this role
Job title: Product Complaint Specialist II
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 report quality metrics to assess QMS performance and identify opportunities for improvement. Serve as a Quality representative in cross-functional meetings; provide guidance, clarification, and coaching to stakeholders on quality principles and QMS expectations. Review and approve documentation (e.g., procedures, reports, assessments) Support external regulatory audits, certification audits, and customer audits by providing documentation, records, and subject-matter expertise. Promote compliance and continual improvement of QMS processes and procedures across the organization. Assist during internal and external audits of the complaint-handling program. Other duties as assigned.
Experience and Qualifications Bachelor’s degree in Biology, Chemistry, Biochemistry or other Life Sciences or Engineering is required. Education requirements may be substituted by previous experience in customer complaint handling and CAPA management. Minimum of 4 years of experience in biotechnology, medical devices, in vitro diagnostics, pharmaceuticals or related industry required. Previous experience developing metrics, analyzing data and generating reports preferred. Previous experience supporting recalls, corrections, or field actions preferred. ASQ Certification