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Quality Engineer II - NPD and Sustainability

Job description

Quality Engineer II – NPD and Sustainability

Work with one of the world’s leading and largest medical device companies with a large presence here in the West of Ireland. The Galway site has gone from strength to strength with technical transfers coming from other global sites and acquisitions to new product development projects onsite. This role will be directly involved in sustainability and new product development projects within the Endoscopy division.

You will be part of a fast paced team utilising green light thinking to problem solve and further product designs.

Responsibilities: 

  • Be a key contributor to statistical analysis projects, identifying key issues and providing resolutions form product testing.
  • Manage and oversee Non-Conformance activities, ensuring product quality and patient safety is optimised.
  • Utilize your knowledge of QSR and ISO standards to continuously promote best industry practices across Design and Manufacturing departments.
  • Liaise with the Quality Manager and Director on key sustainability and product development issues.
  • Conduct process and product validation techniques and ensure all regulatory requirements are met.
  • Conduct Risk Management according to BSEN 14971 requirements.
  • Implement knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
  • Give guidance to Associate Quality Engineers, Technicians and Inspection Staff.

Requirements: 

  • Must have an honours bachelor’s degree in a STEM discipline with 3 years or more experience in Quality Engineering.
  • Preferably Medical Device or similarly highly regulated industry experience.
  • Working knowledge of the following: FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations.

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

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