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Senior Quality Systems Engineer - Start-up

Job description

Senior Quality Systems Engineer – Start-up  

Responsibilities

  • Manage complaints and the complaint handling system, ensuring that they are dealt with in a proper and timely manner
  • Oversee the CAPA system, CAPAs in full and ensure investigations are carried out in line with notified body requirements
  • Manage the audit schedule both internally and externally
  • Assist in supplier management, selection, approval, monitoring and reporting
  • Take ownership of the document control for the site
  • Monitor MDR requirements for QMS
  • Lead activities for the QMS and ensure certification to ISO, FDA, PMDA regulations
  • Manage the software validation process

 

Requirements

  • Must have at least a diploma in Engineering, Science, QA or similar discipline.
  • Should have 5 years or more experience with a working knowledge of ISO13485, 21CFR 820, MDD/MDR and Risk Management.

 

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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