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Quality Assurance Supervisor - Switzerland  

Bio-Rad (company)


Posted on : 08 March 2017

Project Description

Job Description 
  • Ensure conformity and application of the Quality Management Systems across the facility 
  • Manage customer audits and regulatory inspections 
  • Establish strategies to continuously improve Quality Management Systems that enable DiaMed to efficiently meet customer and regulatory requirements 
  • Collaborate with the business partners to lead the development of systems and processes 
  • Drive projects to select, design and deploy a standardized, integrated set of IT tools for Quality Management Systems 
  • Monitor the foreseen regulatory evolutions to anticipate new requirements and get set for the future         

  Required Skills     
  • Educational background in Biology, Pharmaceutical or related domain (BSc/MSc or equivalent education in Science) 
  • At least 3 - 5 years of experience in Quality Assurance in an In Vitro Diagnostics company or other related industry (Pharmaceutical, Biotechnology, Medical) 
  • Previous successful experience in leadership role 
  • Thorough understanding of ISO Norms 13485, 9001, 14971, the European Directive 98/79/CE and the 21CFR820 
  • Experience with project management, experience in Lean or Six Sigma projects preferred (Certification Lean Green Belt would be a plus) 
  • Either French or German as a native language, with good knowledge of the other language. Very good knowledge in English is compulsory.