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Senior Quality Engineer

  • Pale Blue Dot® Recruitment
  • Limerick

To apply for this job please visit palebluedotrecruitment.recruitee.com.

Our client, a leading medical device company based in Limerick are looking for a Senior Quality Engineer to join the team. This will be a full-time, permanent position where the successful candidate will report to the Chief Operating Officer. The client is looking for someone with all rounded experience who will hopefully come in and develop the quality team.

 

Job Responsibilities include but are not limited to the following:

  • 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

Requirements

  • 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
  • Good leadership skills and ability to influence change
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels

 

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

 

Pale Blue Dot® Recruitment

“The Resource for the MedTech Workforce”

To apply for this job please visit palebluedotrecruitment.recruitee.com.