Beschreibung
Main Responsibilities- Work closely with R&D and Manufacturing Engineering on Design and Process Validations and Qualification of Equipment
- Evaluate, review and approve Validation and Qualification plans and reports and Risk files
- Responsible for complete handling of material returned from the field (RMA) for complaint investigations
- Analyse and report trends and statistical data from investigations with R&D and company management
- Responsible for providing support and communication with external customers to resolve quality issues and other related product concerns
Your profile
- Bachelor or Master's Degree in Electrical Engineering or similar education
- 3 years of experience in a similar position in a highly regulated environment, preferable in Med-Tech industry
- Good knowledge of the Med-Tech Industry regulations (ISO / FDA / GMP)
- Experience in failure investigations in soft- and hardware applications
- In-depth experience in process and test method validation (TMV, IQ/OQ/PQ) and in the application of statistical methods
- Experience in Project Management
- Experience with CAPA processes
- Experience in communication with customers and suppliers
- B1 German B1 English
Michael Bailey International is acting as an Employment Business in relation to this vacancy.