Sr. quality engineer - nogales

Sr. Quality Engineer - Nogales

We are looking for an experienced quality engineer to support our medical device operations. Responsibilities include review and approval of validation protocols, adherence to FDA/GMP/ISO 13485 standards, incident investigations, calibration management, corrective actions, and leading a quality engineering team.

Responsibilities Review and approve validation protocols for new and existing equipment. Participate in planned inspections and investigations of accident incidents for the EHS system. Assist the Manager of Quality Assurance in planning, organizing quality department activities and maintaining standards according to FDA and GMP. Coordinate, review and apply methods of material and process inspection using approved procedures. Develop, validate and verify test methods for products and processes. Execute and control calibration and test equipment to ensure reliable measurements. Contribute to corrective actions and client claims investigati...