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Contact Info
Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

Senior Quality Engineer


Reference:/RH/ABIR-281551 Location: Limerick
Limerick City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Engineer

Life Science Recruitment are exclusively sourcing a Senior Quality Engineer for our client who are based in Limerick. The ideal candidate will have a BSc or BEng with the ability and some team leadership or management experience.



Role/Responsibilities:

  • Lead and drive the quality team in all aspects of the management of the Quality Management Systems
  • Drive quality culture in accordance with our quality policies, guidelines and processes
  • Champion compliance to applicable Global Regulations and standards (eg. US FDA, 21 CFR 820, ISO 13485:2016 and IVDR:In Vitro Diagnostics Regulation)
  • Collaborate with Chief Operating Officer to ensure quality management system is maintained and continually improving
  • Lead all external audits as Quality SME
  • Ensure compliance for manufactured and distributed products.
  • Provide advice and support to colleagues on quality matters
  • Represent quality department in company projects where required.
Education and Experience:


  • A minimum of a Bachelor’s Degree, preferably in a Science or related technical field
  • Min 5 years’ experience in a Medical Device/Diagnostics Company in a similar role
  • Qualified Lead Auditor in ISO 13485
  • Excellent working knowledge of 21 CFR 820 and ISO 13485 standards
  • Knowledge of CE IVD regulations
  • Ability to manage competing priorities in a fast-paced environment