**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Main activities/ Responsibilities:** Ensure change management process (CCRs) is monitored and maintained Have authority to review and approve NCMs/Deviations/CAPAs Conduct internal and supplier audits Final review of the device history record and product release for shipment to Hennigsdorf Review and approval of quality documents and records Provide quality input into projects (i.e. design control, improvement projects) Ensure continuous improvement of quality assurance related processes Establish and maintain KPIs to continuously monitor QA processes and to improve them Provide trainings of all employees working within the quality management system Be the deputy for all quality assurance related activities **Technical competencies:** Bachelor’s degree in engineering or a related field Proven ability in Quality Assurance Familiar with ISO 13485, IVDR 2017/746, MDSAP regulation including 21 CFR 820, Root cause investigation techniques Proficient in English and French, ability to work internationally Technical writing skills for quality documentation and records, proficient with Microsoft word, excel and power point. **Soft skills:** Outstanding self-motivation and ability to collaborate successfully High degree of result and solution oriented Teamwork and communication skills Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.