Validation & Qualification Engineer (m/f/d)

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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 validationExperience in Manufacturing Equipment validationExperience in Test Method ValidationExperienced in IQ/OQ/PQ process proceduresSolid understanding of medical applicationsMonitoring the progress of qualification to other team members Qualification protocol preparationExecution of qualification protocolReport writings and strong documentation skillsProject Management skillsData analysis incl. statistics (MiniTab)Risk Management trough mainly PFMEAFollow document validation trough the companyCollaboration with tester engineers and quality engineersExperience 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 advantageSthree Switzerland is acting as an Employment Business in relation to this vacancy.