Quality Engineer, Nyon

EMS is a global leader in the design, manufacturing, and distribution of precision medical devices used in dental prevention, pain therapy, and urology. With over 40 years of expertise, EMS delivers innovative solutions across three key medical fields:

Dental Prevention– Inventors of Guided Biofilm Therapy (GBT), an evidence-based protocol for biofilm management

Pain Therapy– Leaders in shock wave technologies for musculoskeletal treatments

Urology– Market leaders in endoscopic lithotripsy

Driven by our core values—Respect, Excellence, and Client Orientation—we are committed to delivering clinically proven, minimally invasive treatments that improve patient outcomes worldwide.

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

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