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 u...