Are you passionate about working to create high-quality, innovative medical and drug delivery devices to improve lives? As a Quality Engineer, you’ll play a crucial role in ensuring the quality of life impacting medical devices and combination products. In this role you will ensure continuous improvement of quality systems while supporting the design, development, transfer, and production of medical device and combination products. Gilero, A Sanner Company, partners with Tecma to operate a medical device manufacturing facility in Tijuana, Mexico. We are currently seeking a Quality Engineer to join the TJ team

If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. Join us and be part of a company that values innovation, integrity, collaboration and excellence

Responsibilities
- Support the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and FDA 21 CFR Part 820.




- Assist in the investigation and documentation of non-conformances (NCRs), root cause analysis, and implementation of corrective and preventive actions (CAPAs).
- Participate in internal audits and help prepare documentation for regulatory and customer audits.
- Collaborate with Engineering, Manufacturing, and Regulatory teams to ensure quality requirements are met during product development and manufacturing.
- Review and approve Device History Records (DHRs), incoming inspection results, and production batch documentation.
- Develop and validate measurement and inspection techniques for in-process and finished medical device products, ensuring accuracy, repeatability, and compliance with product specifications and regulatory requirements
- Support production line troubleshooting by identifying quality issues and assisting manufacturing and production teams with containment and resolution.
- Participate in validation

📌 Quality Engineer (Tijuana)
🏢 Gilero, A Sanner Group
📍 Tijuana