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