Engineer Principal Quality – Nogales
Overview Principal Quality Engineer responsible for ensuring quality and compliance of medical products across manufacturing processes.
Responsibilities - Coordinate development of validation protocols for new and existing equipment using approved procedures.
- Assist the Quality manager in planning, organizing activities, and work within the quality department, ensuring systems and standards are maintained in accordance with FDA, GMP, ISO 13485, and 21CFR Part820.
- Ensure maintenance of required certifications and product availability in the global market.
- Coordinate, review, and apply methods of material and process inspection through approved procedures to maintain quality at all manufacturing stages.
- Manage, receive, and control customer complaints via the established claims system to maintain timely responses.
- Analyze process trends, conduct investigations, and use PPM ...