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Quality Assurance Manager (m/f/d)

  • Educational background in Biology, Pharmaceutical or related domain (BSc / MSc or equivalent education in Science)
  • At least 5 years of experience in Quality Assurance in an In Vitro Diagnostics company or other related industry (Pharmaceutical,
    Biotechnology, Medical) - including 3 years in a management role
  • Thorough understanding of ISO Norm 13485, the European Directive 98/79/CE and IVDR and the 21CFR820
  • Strong leadership, people management and coaching skills
  • Experience with project management, experience in Lean or Six Sigma projects preferred (Certification Lean / 6 σ Green Belt would be a plus)
  • Manage, lead and coach the Quality Assurance System team
  • Ensure conformity and application of the Quality Management Systems across the facility
  • Manage customer audits and regulatory inspections
  • Drive strategies to continuously improve Quality Management Systems that enable Bio-Rad to efficiently meet customer and regulatory requirements
  • Collaborate actively with the business partners to develop quality mindset
  • Monitor the foreseen regulatory evolutions to anticipate new requirements and get set for the future

» Job description

DiaMed GmbH
1785 Cressier [CH]