Work Schedule

Environmental Conditions

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