Quality Engineer – Medical Devices

About the role

EMS is seeking a Quality Engineer to act as the internal expert on biocompatibility, sterilization, and reprocessing of reusable medical devices. Reporting to the Quality Assurance Group Leader, you will ensure product compliance with regulatory standards and support R&D throughout the product lifecycle.

Key responsibilities

• Provide expertise on biocompatibility and reprocessing of reusable medical devices.
• Lead sterilization process validation and ensure compliance with applicable standards.
• Review and validate sterilization documentation for finished sterile products.
• Support product release by confirming documentation completeness and regulatory compliance.
• Contribute to technical documentation, regulatory files, and risk management activities.
• Collaborate with Regulatory Affairs, R&D, and other stakeholders to ensure compliant product development.
• Assist with EHS-related topics and implementation of best practices within your scope.

Required profile

• Degree in Engineering, Life Sciences, or a related field.
• 3–5 years of experience in Quality, Regulatory, or a related role within the medical device industry.
• Strong knowledge of ISO 13485 and the EU Medical Device Regulation (MDR).
• Fluent in English; French or additional languages are a plus.

Required skills

• Biocompatibility assessment
• Sterilization process expertise
• Reprocessing of reusable medical devices
• ISO 13485 compliance
• EU MDR knowledge
• Risk management in product development