Beschreibung
We are looking for a Production Engineer for one of our clients in the canton of Vaud (VD) to work on medical device systems.
Production Engineer
The position Reporting to the Head of Supply Chain & Manufacturing, you are the on-site technical reference for production equipment and processes. You play a key role in the performance, reliability and compliance of manufacturing operations.
Your main tasks
Production & process: daily technical support to operators and technicians, problem solving (root cause analysis, CAPA), equipment qualification and validation (IQ/OQ/PQ), writing and maintaining SOPs and work instructions.
Quality & compliance: management of non-conformities, leading Change Controls, active participation in internal and external audits, strict application of regulatory frameworks.
Continuous improvement: deployment of Lean tools (5S, Kaizen, OEE), monitoring production KPIs, contributing to industrialisation and capacity expansion projects.
EHS: application of safety standards, updating risk analyses, promoting a safety culture on site.
Profile sought
- Bachelor+4/5 in engineering, with a minimum of 7 years’ experience in manufacturing within a regulated environment (pharma, biotech, medtech)
- Strong knowledge of GMP/GxP, ISO 13485 standards, ideally IVDR
- Practical experience in qualification/validation of production equipment
- Comfortable with ERP/MES tools
- Bilingual French/English essential
- Cross-border permit or work authorisation in Switzerland
