Senior Quality Engineer

1 month ago


Limerick, Ireland Pale Blue Dot® Recruitment Full time

Our client, a medical device engineering company based in Limerick who specialize in manufacturing precision components are seeking a Senior Quality Engineer to join their team.

Responsibilities include but are not limited to:

  • Specification development, CTQ mapping, test method development and validation, process validations and implementation of CCP within the process, using error proofing, process monitoring, SPC.

  • Complaint handling, NC management, Risk and Impact assessment, CAPA, Root cause investigation and solution development and verification and Change control.

  • Supplier Quality Management.

  • Product release.

  • Product test and release planning, change management and audit.

  • Critical thinking and technical writing.

  • Quality lead on multi/cross functional teams to achieve milestones and results.

  • Represents the company in Customer interactions relating to product process and system quality elements in a professional, constructive, and commercially aware manner.

  • Ensures that customer product requirements are defined and implemented within the site QMS

  • Engage with the new product development team to ensure a smooth transition from development to production.

  • Identify and implement continuous improvements across the board and takes initiatives to make things better every day.

  • Owns and drives the Safety/Quality/Service/Cost Metric for the VS.

  • Minimum Level 8 Qualification.

  • Minimum of 5 years of direct QMS experience

  • Validation experience, MSA experience and Gauge R&R experience

  • On the job training will be provided for the right candidate.

  • Strong written and oral communication skills.

  • Experience working with medical device regulations is desirable.

  • Good computer skills in usage of MS Office Suite

  • Working knowledge of EN ISO 13485, FDA QSR 21 CFR Part 820 and principles of GMP in the Medical Device Industry.

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-



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