QA Engineer MDR

Vor 5 Tagen


Basel, Schweiz Recooty Vollzeit
  • Build and maintain certified MDR Quality Management System
  • Lead product registration process with Notified Body
  • Represent the QMS as deputy PRRC
  • Maintain local training compliance
  • Lead and participate in internal audits
  • Provide Quality related trainings
  • Track and report KPIs
  • Supplier qualification including leading of audits

Skills Required:

  • Bachelor’s degree in Life Science or equivalent
  • Minimum of 5 years’ experience in Regulatory Affairs, Clinical Affairs or Quality Assurance
  • Record of success and broad understanding of contemporary quality practices as they apply to product development, manufacturing, and commercial operations
  • Proven expertise in the design and implementation of quality processes in world-class medical device manufacturing
  • Expertise in MDR, cGMP and other Regulatory compliance requirements
  • Experience in software development in the medical device context
  • Self-confidence and the ability to work with all levels of organization
  • Operates in a way that never compromises ethics and integrity
  • Advanced leadership skills
  • Ability to understand and adapt to different cultures and market needs
  • (Inter-)national travel as required by business (up to 10%)
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