Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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