Vacancy caducado!
- 4 to 5 years of design quality (New product design – R&D) experience in Medical devices
- Knowledge in 21 CFR Part 820, ISO 13485, ISO 14971, EU MDD & MDR regulations
- Experience in Risk management – Hazard Analysis, DFMEA, UFMEA
- Experience in Test method development & validation associated to design verification
- Experience in design verification protocol & reports
- Experience in reviewing product / system requirements, design outputs, trace matrix
- Experience in sample selection for testing
- Experience in Minitab, Statistical analysis
- Experience in cross functional team interactions like R&D, Clinical, Regulatory, Manufacturing
Vacancy caducado!