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Senior Quality Engineer

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 20783

Are you a passionate Senior Quality Engineer looking for an exciting new opportunity to work with a leading medical device company in Ballina? Look no further! We are seeking an experienced Senior Quality Engineer to join our Client on a permanent, full-time basis. This role offers the successful candidate opportunities for growth and advancement within the company.

Responsibilities | Detailed Job Description Available on Request

As a Senior Quality Engineer, your duties will include:

  • Developing and implementing Master Validation Plans, Risk Assessments, and leading QE activities in the Value Stream.
  • Developing and completing DV/IQ/OQ/PQ protocols.
  • Contributing to the development of FAT/SAT protocols.
  • Executing Validation Protocols, root cause deviations, and generating validation reports.
  • Developing product specifications, drawings, and quality plans in conjunction with NPD personnel.
  • Providing QE support for New Product Development (NPD) projects.
  • Conducting Process Risk Management/FMEA.
  • Completing internal audits per the audit schedule.
  • Coordinating and implementing process capability analysis on catheter processes.
  • Completing CAPA investigations.
  • Leading Hollister Production System (HPS) audits for the department.
  • Supervising Quality Engineers and Associate Quality Engineers during project activities.


As a Senior Quality Engineer, you will need to have:

  • A Bachelor's degree in Engineering/Science Discipline and Quality Engineering Qualification.
  • 6+ years of experience in the Medical Device Industry utilizing automated equipment.
  • Experience in statistical analysis/SPC/validation of automated equipment.
  • Experience in people management.

If this Senior Quality Engineer role interests you, please contact Emma Cawley today.