Quality System 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: 

  • BSc. 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.
  • Must be authorised to work in Ireland

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

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