Requirements

Required education level
Ad. Federal PET / Fed. PET Diploma, Bachelor, Master
Required experience
Over 5 years
Required language knowledge
English German
Required skills
English REGULATORY AFFAIRS english regulatory affairs ISO 13485 production validation 21 CFR 820 Regulatory Affairs medical devices Validation ENGLISH Complaints Production complaints PRODUCTION Research & Development Medical Devices Regulatory affairs Research & development german Design Assurance Design Control Medical devices MDR change control German design control Risk Management risk management

Details

Location
Other countries
Term of employment
Full time
Sector
Medical technology
Professions
Regulatory Affairs Biology / Biotechnology Chemistry Management / Project Managemen... Pharmaceuticals Pharmacy / Drogstore Production Research & Development / Labor...

Description

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)

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, 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

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.

NonStop Consulting
Jun 17, 2022

Contact info

NonStop Consulting
Andrew Boroky
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Not available