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 meas...