MISSION

As a Quality Engineer, you will report to the Quality Assurance Group Leader and act as an internal expert in biocompatibility, sterilization, and reprocessing of reusable medical devices.

You will contribute to ensuring compliance with applicable regulatory requirements (including ISO 13485 and MDR) and support R&D and product lifecycle activities with your technical expertise.

TASKS & RESPONSIBILITIES

• Act as the internal expert for biocompatibility and reprocessing of reusable medical devices
• Act as the internal expert for sterilization processes and requirements
• Ensure compliance of products with applicable standards and regulatory expectations in these areas

• Review and validate sterilization documentation for finished sterile products (for which EMS is the legal manufacturer)
• Support...