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
Biocompatibility & Sterilization Expertise
* 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
Product Compliance & Documentation
* Review and validate sterilization documentation for finished sterile products (for which EMS is the legal manufacturer)
* Support product release activities by ensuring documentation completeness and compliance
* Contribute to technical documentation and regulatory files related to biocompatibility and sterilization
R&D & Product Lifecycle Support
* Support R&D projects by providing expertise in biocompatibility, sterilization, and reprocessing requirements
* Contribute to risk management and product development activities
* Collaborate with Regulatory Affairs, R&D, and other stakeholders to ensure compliant product development
EHS Contribution (Shared Responsibility)
* Contribute to EHS-related topics in coordination with internal stakeholders
* Support the implementation and follow-up of EHS practices within your scope
EDUCATION & PERSONAL SKILLS
* Degree in Engineering, Life Sciences, or a related field
* Minimum 3–5 years of experience in Quality, Regulatory, or a related role within the medical device industry
* Strong expertise in biocompatibility and sterilization is required
* Knowledge of reprocessing of reusable medical devices is a strong advantage
* Good understanding of applicable standards and regulations (including ISO 13485 and MDR)
* Strong analytical and problem‑solving skills
* Ability to work cross‑functionally and communicate effectively
* Structured, rigorous, and detail‑oriented mindset
* Fluent in English; French and/or any additional language is a strong advantage
WHY JOIN EMS?
At 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.
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