Senior Quality Systems Engineer

Job description

Senior Quality Systems Engineer

Work with one of the worlds’ leading medical device development companies who have developed a centre of excellence and research in Galway. This site has thrived with several tech transfers and specific developmental projects focused on improving patient safety. This role will focus on assisting to develop the systems and processes onsite.

What will you be doing:

  • Act as a key resource for developing regulatory and standard compliance, ensuring the Quality Systems match up with MDR, MDD, ISO, FDA and other regulatory bodies
  • Maintain and Improve Quality Systems as you see fit
  • Continuously promote awareness of regulatory compliance and ensure continuous improvement of Quality Systems
  • Lead and manage internal QMS audits and investigate potential NCRs
  • Complete QMS Risk Management
  • Perform timely CAPAs
  • Complete trend analysis as required

What do you need:

  • Level 8 degree within a Quality related discipline or other relevant discipline
  • 5 years or more experience working with Quality Systems or in a similar role within medical devices
  • Should have people management skills


To apply for this position please contact Aaron Long at Sigmar Recruitment T: +353 91 749265

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