Beschreibung
(Sr.) Quality Engineer(work focus: Qualifications, Validations, CAPA, Process improvements)
Date:
April months, with possible extension or permanent option
Department:
Quality Assurance
Main Responsibilities
- Initiate and manage projects to ensure continuous product and process optimization
- 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
- Prepare quality-related documents to comply with the regulatory requirements of the Med-Tech industry
- Support problems and questions arising in the production or in the other areas of the organization (also internationally) and propose adequate solutions
- Investigate to highlight errors and deviations, perform root-cause analysis and implement effective corrective actions
The profile
- Master's Degree or similar education in biomedical or electronical engineering or similar
- Min 5 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 / MDR)
- In-depth experience in process and test method validation (TMV, IQ/OQ/PQ) and in the application of statistical methods
- Strong engineering and project management skills
- Solid understanding of risk management and FMEA process
- Experience in Project Management preferred
- Experience with CAPA and root cause analysis processes
- Very good written and spoken knowledge of German and English
- Experience in Software Validation a plus
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.