The Complaint Specialist is responsible for leading the end-to-end customer complaint management process, ensuring thorough, timely, and compliant investigations while driving data-based decisions to reduce product failures. Is responsible for complaints final evaluation and escalation activities. This role serves as the technical owner of complaint handling and risk analysis, transforming field data (complaints, remakes, failures) into actionable insights that improve product design, process performance, and customer experience. The Complaint Specialist also leads and develops Quality Technicians, ensuring high-quality execution, accurate documentation, and efficient backlog management. Responsible for ongoing adherence to external regulations as required by FDA’s GMP, ISO 13485 and MDSAP. RESPONSIBILITIES: Lead investigation, evaluation, and closure of customer complaints in compliance with FDA, ISO 13485, and MDSAP requirements. Ensure all investigations are technically sound, complete, and properly documented. Assess complaint severity, risk level, and need for escalation (including potential health and safety impact). Approve investigation outcomes and final decisions. Assign, prioritize, and monitor workload to ensure timely complaint closure and backlog control. Analyse complaint, remake, and failure data to identify critical variables (material, design, process), trends by product, customer, or supplier, emerging quality risks and severe quality issues. Develop analytical reports and dashboards to support operational and management decisions. Translate data into actionable insights to reduce failure rates and improve product performance. Define corrective and preventive actions based on structured root cause analysis (5 Whys, 8D, DMAIC). Drive closure of quality complaints with strong technical justification. Identify recurring and systemic risks in products and processes. Evaluate potential impact on customers and business operations. Qualification requirements: Bachelor’s Degree in Engineering (Quality, Industrial, Biomedical, or related field). 2 years related work experience in complaint handling or quality engineering in a medical manufacturing company. Work experience in the following fields: Analysis of failures and analyses to develop corrective action through the continuous improvement process. Problem solving resolution by means of route cause/problem solving analysis (5whys, 8Ds, Ishikawa, DMAIC). NCR’s handling. CAPA system. #J-18808-Ljbffr