Senior Engineer, Sterilization and Environmental is responsible for planning, coordinating and directing the quality assurance program designed to ensure continuous compliance with regulations regarding sterilization and environmental activities consistent with established standards. This position reports to the Sterilization and Biocompatibility Manager and is part of the Quality Assurance team located in Tijuana, Baja California, México and will be an on-site role.

• Conduct periodic and special validations of sterilization processes (Radiation and EtO) at the manufacturing facility, including coordinating samples, shipping, laboratory testing, and documenting results according to ISO 11137 and ISO 11737.
• Review and track sterilization results from contractor sterilizers to ensure compliance with Device History Record requirements and support final release of sterile products.
• Analyze statistical data for ster...