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 investigations.
- Maintain controlled environment and comply with security requirements.
- Analyze statistics to monitor non‑conforming products and compute DPM of receipt, process and packaging.
- Provide training and maintain training needs system.
- Ensure compliance with quality standards and regulations (ISO 13485, FDA/GMP).
- Lead the quality engineering group to ensure compliance with validation requirements and product specifications.
- Improve inspection processes and sampling plans.
- Lead improvement projects with the greatest plant impact.
Qualifications
- Graduate professional in Industrial Engineering or related engineering discipline.
- Minimum 4 years of experience in quality management for medical devices.
- Strong knowledge of statistics & process capability (Minitab, PPK, hypothesis testing).
- Experience with problem‑solving tools (5 Whys, Ishikawa, RCA).
- Exposure to validation processes (IQ/OQ/PQ, MVP, etc.).
- Advanced English level.
- Previous people‑leadership expe