QA Manager

QA Manager - key role - high tech products in the Life Sciences - Switzerland
Located in Switzerland's Northwest while still in the German speaking area, our client is a developer and manufacturer of high tech Medical Device products, working in collaboration with the Pharma industry. Currently in a strong growth phase, they are looking for a QA Manager to take responsibility for compliance of development projects in production to local and international regulations cGMP, ISO 13485, CFR Part 820 and FDA. Further tasks to include:
Supervision of daily Quality Assurance tasks, in particular product releases, change management, quality documentation and processing of deviation reports
Review and approval of processes and documentation (e.g. design verification/qualification and validation documents) arising in development and industrialisation projects
Collaboration in internal, customer, authority and supplier audits
Management of continous process improvement projects
Typically we'd expect to see a German/English speaking QA trained professional with strengths in validation and qualification of production equipment (including computer software validation), with experience in project management, risk based decision making, and competent in using SAP and Quality tools (FMEA, SPC)
**KEYWORDS**: Medical Devices, Research & Development, Design Assurance, Design Control, R&D, risk management, complaints, production, change control, validation, Engineer, German, English, 21 CFR 820, MDR, ISO 13485, regulatory, Medical Device jobs, Nonstop recruitment
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