Quality Engineer (Medical Device)

We are currently partnering with a global medical technology organisation seeking a Quality Engineer to support manufacturing quality activities within a regulated production environment. This position is based in St. Gallen, Switzerland and offers the opportunity to contribute to product quality, compliance, and continuous improvement initiatives within a collaborative engineering setting.

You will be responsible for:

• Supporting quality assurance and development activities across commercial manufacturing processes
• Ensuring adherence to internal quality systems as well as international regulatory standards (e.g. ISO frameworks, MDR and other applicable guidelines)
• Collaborating cross‑functionally with engineering teams on risk management activities, including FMEA and maintaining risk documentation
• Participating in validation and re‑validation of manufacturing processes and test methods, including protocol development, review and reporting
• Providing quality support to manufacturing teams, ensuring processes remain compliant and efficient
• Contributing to process qualification activities (IQ, OQ, PQ), including review of validation documentation
• Supporting CAPA processes, including root cause analysis and implementation of corrective and preventive actions
• Acting as a subject matter expert in quality during audits and inspections

An ideal candidate should have the following qualifications:

• Bachelor's degree in an engineering or scientific discipline (e.g. mechanical, process, materials, chemical or similar)
• Initial professional experience within a regulated manufacturing environment (e.g. medical devices or comparable industry)
• Working knowledge of relevant regulatory standards such as ISO 13485, ISO 14971, MDR or equivalent frameworks
• Strong analytical mindset, with a structured, detail‑oriented approach to problem solving
• Ability to work effectively in cross‑functional and international team environments
• Experience with statistical tools or methodologies (e.g. DOE) is advantageous
• Fluent German & English (both written and spoken)

What We Offer

• Competitive compensation
• Exposure to a highly regulated, innovative medical technology environment
• A collaborative and international workplace with opportunities for professional growth

If this opportunity interests you, please apply!

NOTE: Only shortlisted candidates will be contacted. Only candidates with the right to work in Switzerland can be considered (e.g., EU citizens or holders of a valid Swiss work permit).