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QA Engineer MDR

skilltec
Full-time
On-site
Basel, Basel, Switzerland
QA Engineer


Responsibilities:

  • Build and maintain certified MDR Quality Management System
  • β€’ Lead product registration process with Notified Body
  • β€’ Represent the QMS as deputy PRRC
  • β€’ Maintain local training compliance
  • β€’ Lead and participate in internal audits
  • β€’ Provide Quality related trainings
  • β€’ Organize site Management Review
  • β€’ Track and report KPIs
  • β€’ Supplier qualification including leading of audits
  • β€’ Site QARA projects



Skills Required:

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