Manufacturing Software Validation

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Plan, organize and ensure the realization and completion of manufacturing software validation and manufacturing equipment qualification for medical devices.Functional Experience Requirements:Experience in Manufacturing Software validationExperience in Manufacturing Equipment 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 documentationProject 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 requiredOther competencies:Fluently in French and English

If you are interested in this or a position please send me your updated CV to my email address: m.tvrdon(at)realstaffing.com I am looking forward hearing back from you and wishing you a great week ahead. Kind Regards,Marco TvrdonRecruitment Consultantm.tvrdon(a)realstaffing.comTel.: +41 (0) 44 588 2640Sthree Switzerland is acting as an Employment Business in relation to this vacancy.