On behalf of our client, a leading international MedTech company, we are currently looking for an experienced Manufacturing Engineer Consultant for a long-term project running through December 2027 in Zurich!
- Location: Zurich, 100% on site
- Workload: 100%
- Expected period: August 2026 to end of December 2027
- Target start: Beginning of August 2026
Objective:
Support the reduction of the current NCMR and SCN workload, including investigation, documentation, coordination, and closure activities in line with applicable QMS and regulatory expectations.
Required profile:
- Bachelor’s or Master’s degree in Electrical, Mechanical, Industrial, Biomedical Engineering or similar
- 5–8+ years of relevant experience in the MedTech industry
- Knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971, IEC 60601-1, MDSAP, GMP and GDP
- EU MDR experience
- Supplier management experience, including occasional supplier visits
- FMEA / risk analysis experience
- Strong cross-functional coordination skills
- English B2–C1
- Accurate documentation style and strong analytical problem-solving skills
- Proficient in PowerPoint, Word, Excel and Visio
Preferred:
- SAP
- Windchill
- Epiq or equivalent CAPA / SCN / NCMR system
- Power BI
- TMV/IMV, IQ/OQ/PQ
- Minitab or similar statistical tools
