Ph3MISSION /h3 pAs 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. /p pYou will contribute to ensuring compliance with applicable regulatory requirements (including ISO 13485 and MDR) and support RD and product lifecycle activities with your technical expertise. /p h3TASKS RESPONSIBILITIES /h3 bBiocompatibility Sterilization Expertise /b ul liAct as the internal expert for biocompatibility and reprocessing of reusable medical devices /li liAct as the internal expert for sterilization processes and requirements /li liEnsure compliance of products with applicable standards and regulatory expectations in these areas /li /ul bProduct Compliance Documentation /b ul liReview and validate sterilization documentation for finished sterile products (for which EMS is the legal manufacturer) /li liSupport product release activities by ensuring documentation completeness and compliance /li liContribute to technical documentation and regulatory files related to biocompatibility and sterilization /li /ul bRD Product Lifecycle Support /b ul liSupport RD projects by providing expertise in biocompatibility, sterilization, and reprocessing requirements /li liContribute to risk management and product development activities /li liCollaborate with Regulatory Affairs, RD, and other stakeholders to ensure compliant product development /li /ul bEHS Contribution (Shared Responsibility) /b ul liContribute to EHS-related topics in coordination with internal stakeholders /li liSupport the implementation and follow-up of EHS practices within your scope /li /ul bEDUCATION PERSONAL SKILLS /b ul liDegree in Engineering, Life Sciences, or a related field /li liMinimum 3–5 years of experience in Quality, Regulatory, or a related role within the medical device industry /li liStrong expertise in biocompatibility and sterilization is required /li liKnowledge of reprocessing of reusable medical devices is a strong advantage /li liGood understanding of applicable standards and regulations (including ISO 13485 and MDR) /li liStrong analytical and problem‑solving skills /li liAbility to work cross‑functionally and communicate effectively /li liStructured, rigorous, and detail‑oriented mindset /li liFluent in English; French and/or any additional language is a strong advantage /li /ul h3WHY JOIN EMS? /h3 pAt EMS, you will join a dynamic and international environment where quality and innovation are at the core of everything we do. You will have the opportunity to work on impactful products, collaborate with multidisciplinary teams, and contribute to continuous improvement in a regulated and fast‑evolving industry. /p /p #J-18808-Ljbffr