\\n QA Manager \\xe2\\x80\\x93 key role \\xe2\\x80\\x93 high tech products in the Life Sciences \\xe2\\x80\\x93 Switzerland

Located in Switzerland\\xe2\\x80\\x99s 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 number of QA Managers to take responsibility for project/product work spanning development into production. On a day to day basis this means :

• Supporting the transfer of development projects in production, ensuring compliance to regulations including cGMP, ISO 13485, CFR Part 820 and FDA Guidelines
• Responsibility for Quality Assurance tasks wrt product release, change management, quality documentation and processing of deviation notifications
• Participation in internal and external Audits (Supplier, Notified Body, Competent Authority, customer)
• Checking design verification / qualification and validation documentation for development and industrialisation projects, and coordinate release
• Project management of Quality projects

Typically we\\xe2\\x80\\x99d expect to see a German/English speaking QA trained professional with (ideally) good working knowledge of cGMP, ISO 13485, CFR Part 820 and FDA Guidelines, competency in using SAP and Quality tools (FMEA, Kaizen, SPC), detail oriented professional (wrt documentation) and with some project management experience.

Short and sweet, a hands on quality engineering role with great potential for career development. For more information on this vacancy, or any other QA opportunities within the Swiss Medical Devices sector, please contact the Senior Consultant Andrew Boroky by applying with your resume in WORD format, plus scanned copies of training certifications and ArbeitsZeugnisse (work references).

KEYWORDS: Medical Devices, Development, Design Assurance, Design Control, risk management, complaints, production, change control, validation, audit, verification, qualification, German, English, 21 CFR 820, MDR, ISO 13485, cGMP, regulatory, Medical Device jobs, Nonstop recruitment

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in Switzerland, Luxembourg, the Czech Republic, UK, Romania, and the USA, and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.\\n \\n \\n \\n \\n \\n

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