Engineer Principal Quality - Nogales

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 to measure process capacity. Apply industrial engineering principles to process m...