Job Detail

• Job TitleQuality Assurance & Validation Consultant-Medical Devices f/m


• Vacancy Reference NumberPRCH-ALTZUR-QASVC-201507101


• Work SiteSwitzerland / | CHE - All Regions / Zürich


• Contract TypePermanent [Full-Time]

Your role

• Initiating improvements of Quality Management System compliance


• Ensuring Regulatory requirements to MDD 93/42/EEC.


• Ensuring consistent implementation of the QMS processes.


• Performing the review and approval of Design Control Documents, SOPs 


• Assisting in Risk Management activities: FMEA and Reliability studies 


• Handling of Change Requests, Non Conformities and CAPAs


• Planning and execution of Verification & Validation activities. 

Your profile

• Master in Biomedical or Mechanical Engineering (ETH/TU/TH/FH)


• At least 3 years of experience in Quality Assurance in MedTech.


• Excellent knowledge of European and US regulations, procedures, standards 


• Excellent knowledge of guidelines (MDD, QSR, ISO 13485, ISO 14971)


• Very good IT skills (Sharepoint, MS Project, Excel)


• You are capable to deliver on time and with high quality


• You speak German fluently, possess excellent writing skills in English


• You are mobile for projects in the German part of Switzerland