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Senior Design Quality Assurance Engineer

Job description

Senior Design Quality Assurance Engineer

A growing medical device and technology company providing devices, instruments and reagents within the MedTech sector. This current position based in Limerick is within a brand-new site for this global multinational and will be part of several NPD and NPI projects while also being a key part of the overall growth of the company. You will report into the Quality Manager for the research centre but act as lead for Design Assurance activities.

Responsibilities: 

  • Work on technology transfers into the large research centre, leading design control, design assurance and design development projects and activities
  • Assist with developing and managing the QMS onsite to support design activities
  • Provide guidance and lead the team for design controls according to 21CFR 820 regulations during new product development
  • Review product development documentation and product development tests, completing risk analysis
  • Ensure total compliance to regulatory and notified body requirements and standards
  • Manage the risk management plan and complete DFMEA activities
  • Review and approval of Verification and Validation plans, protocols and reports
  • Complete IQ and OQ approvals and act as liaison for product investigations

 

Requirements: 

  • Must have 5 years or more experience within the medical device industry or an industry that is similarly highly regulated. Ideally ISO13485 or FDA exposure
  • Honours degree in STEM subject

 

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

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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