Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob DescriptionMain activities/ Responsibilities:Ensure change management process (CCRs) is monitored and maintainedHave authority to review and approve NCMs/Deviations/CAPAsConduct internal and supplier auditsFinal review of the device history record and product release for shipment to HennigsdorfReview and approval of quality documents and recordsProvide quality input into projects (i.e. design control, improvement projects)Ensure continuous improvement of quality assurance related processesEstablish and maintain KPIs to continuously monitor QA processes and to improve themProvide trainings of all employees working within the quality management systemBe the deputy for all quality assurance related activitiesTechnical competencies:Bachelor’s degree in engineering or a related fieldProven ability in Quality AssuranceFamiliar with ISO 13485, IVDR 2017/746, MDSAP regulation including 21 CFR 820, Root cause investigation techniquesProficient in English and French, ability to work internationallyTechnical writing skills for quality documentation and records, proficient with Microsoft word, excel and power point.Soft skills:Outstanding self-motivation and ability to collaborate successfullyHigh degree of result and solution orientedTeamwork and communication skills
