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.