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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