Archiviertes Projekt - Validation & Qualification Engineer (m/f/d)

Validation & Qualification Engineer



Plan, 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.