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Quality Engineer

  • Pale Blue Dot® Recruitment
  • Galway

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

The Role

Reporting to the Director QA/RA, the position will be challenging and will require an ability to work autonomously.  The position requires an experienced and proven candidate with a background in Quality and Regulatory control of Medical Devices. The successful candidate will work as part of a team to maintain high quality/performance standards across the company.


Job Responsibilities include but are no limited to the following:

  • Develop and maintain documentation in compliance with FDA , ISO, MDD requirements
  • Actively participate in the Documentation control process
  • Review / Approve / Release final product documentation
  • Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations
  • Participate / Lead Risk Analysis initiatives e.g. FMEA
  • Initiate / Approve Reworks
  • Initiate / Support implementation of effective Corrective / Preventive Actions
  • Support the Environmental monitoring process
  • Support activities associated with Sterilization
  • Act as the QA representative for Supplier Quality management activities
  • Represent QA as part of the Material Review Board
  • Act as the QA representative on Design Services Projects / Changes
  • Initiate / Approve Validation protocols and reports (IQ, OQ, PQ)
  • Initiate / Approve Engineering Change notices
  • Process Customer Complaints and manage customer replies
  • Support Notified Body / Regulatory Agency / Customer Audits
  • Perform Internal and Supplier Audits
  • Collate and trend Key performance indicator data on a monthly basis
  • Actively participate in Management Review & Compliance meetings
  • Performs other related duties, as assigned



  • A degree in manufacturing engineering, quality engineering, life science or related field and a minimum of 3 yrs. experience of working as a Quality Engineer within the Medical Device Industry.
  • Candidate must be highly motivated with excellent communication skills and proven ability to work as part of a team.
  • Experience of using Lean Manufacturing Tools and Techniques an advantage
  • Quality Certification and Lead Auditor Certification while not mandatory would be an advantage.


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.