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).
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