Quality Systems Manager with QMS experience within medical devices, required by market-leading Galway multinational. The successful candidate will manage processes and people to ensure regulatory compliance

Key Responsibilities:

  • Manage the Quality System team and ensure that both regulatory and business requirements are met
  • Responsible for processes within Document Control, Customer Quality, and Master Data area
    Leader in driving improvement initiatives in the Quality Management system across the site
  • Drive and enhance a compliance culture though-out the site
  • Providing Quality Systems support for all business units and sites
  • Preparing for and supporting external audits
  • Ensure adequate monitoring and measurement of processes
  • Ensure Quality System processes are lean, compliant, user-friendly
  • Be responsible for Health & Safety within assigned areas

 

Requirements: 

  • Level 8 B.Sc. Degree in Quality Assurance or Science / Engineering with an additional qualification in Quality Assurance
  • 3+ years Quality Systems Manager experience within the Medical Device industry
  • Excellent working knowledge of ISO13485 and FDA QSR requirements
  • Regulatory experience / knowledge
  • Good organization, supervisory, technical writing and investigation skills
  • Proven ability to influence

Please contact Emer Smith to discuss in confidence
00353578638188       
emer@emtechrecruitment.ie

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