Don't just check quality — shape it.
We're looking for a Quality Engineer (80–100%) for an established medical technology manufacturer in western Switzerland. This is a role with real ownership: responsibility, influence, and visible impact on products that matter.
What you'll own:
* Upholding the highest quality standards in a fully regulated environment (GxP, ISO 13485, FDA 21 CFR Part 820)
* Managing changes, deviations, 8D reports and effective CAPA
* Planning and leading internal and external audits — customers, authorities and suppliers
* Coordinating qualifications and process validations (IQ/OQ/PQ)
* Owning batch release — ensuring only flawless product moves forward
* Driving continuous improvement through Lean methods
What you bring:
* Technical education (HF/FH) with further training in quality management
* Several years in quality assurance in a production setting (ideally MedTech / ISO 13485)
* Knowledge of Lean Management, CAQ and ERP systems
* German (fluent), strong English (other languages are an advantage)
Interested or just curious? Send us a message — happy to share more in confidence.
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