Beschreibung
Validation & Qualification EngineerPlan, organize and ensure the realization and completion of validation and manufacturing equipment qualification for medical devices.
Functional Experience Requirements:
- Experience in Manufacturing Software validation
- Experience in Manufacturing Equipment validation
- Experience in Test Method Validation
- Experienced in IQ/OQ/PQ process procedures
- Solid understanding of medical applications
- Monitoring the progress of qualification to other team members
- Qualification protocol preparation
- Execution of qualification protocol
- Report writings and strong documentation skills
- Project Management skills
- Data analysis incl. statistics (MiniTab)
- Risk Management trough mainly PFMEA
- Follow document validation trough the company
- Collaboration with tester engineers and quality engineers
- Experience with applicable norms (e.g. ISO13'485; 21CFR part 11, 21CFR part 820, IEC 62304 - FDA, MDD, MDR and other)
Required Degree/Certificates:
- Master's degree in electronic engineering / quality or equivalent required
Other competencies:
- Fluently in English, either German / French of advantage
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.