Quality Engineer-Customer Complaints

Job Duties: PRIMARY OBJECTIVEThe Quality Engineer acts as the primary owner of the customer complaint and corrective action process. This role ensures that manufactured products meet high standards through timely investigation, containment, and resolution, while maintaining strict compliance with ISO 9001 requirements and internal Quality Management System (QMS) procedures. DUTIESComplaint & CAPA Management: Manage the full lifecycle of customer complaints from initial receipt through final closure, ensuring all actions are executed on time. Investigation & Root Cause Analysis: Lead and document comprehensive root cause investigations for multiple concurrent projects. Risk Management: Apply risk-based thinking to evaluate the severity and impact of quality issues to determine the appropriate organizational response. Containment & Control: Oversee the segregation and production holds of nonconforming outputs to prevent further quality escapes. Traceability & Scope: Use product identification and traceability records to define the exact scope and impact of quality deviations. Communication: Develop clear, accurate written technical responses for customers and provide verbal status updates to internal stakeholders. Effectiveness Verification: Implement corrective actions and perform formal verification to ensure the underlying issues are resolved. Data & Improvement: Partner with the broader Quality team to analyze data trends, support management reviews, and drive continuous improvement. Audit Support: Serve as a key contributor during internal, customer, and third-party audits to demonstrate QMS effectiveness. Documentation: Maintain precise, controlled documented information for all complaints and CAPA activities.