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Senior Quality Systems Engineer - Start-up

Job description

Senior Quality Systems Engineer – Start-up

Responsibilities 

  • Act as an SME and leader for application and development of quality systems onsite with specific regard to ISO standards including ISO13485:2016 & ISO14971:2007 or MDR regulations on MDD93/42/EEC, MDR/2017/745, SOR/98-282. 21CFR820 & 21CFR11
  • Promote awareness onsite and implement best industry practice, acting as a champion for continuous improvement in an innovative and fast paced environment.
  • Implementing internally all regulatory and legal requirements, working directly with the Senior Quality Manager to align internal QMS requirements for ISO13485:2016 & 21CFR820.
  • Lead and support regulatory inspections and notified body audits.
  • Conduct internal audits to support the supplier quality management process.
  • Compile management review data, quality metrics and help in driving continuous improvement for the quality system.
  • Provide input into equipment and process validation and test method validation.

 Requirements: 

  • Level 8 degree or post graduate degree in quality management or similar
  • 5 years or more experience in a medical device manufacturing environment with direct working experience in a QMS role.
  • Working knowledge of FDA, ISO13485 or CE Registration process.
  • Experience in regulatory submissions is preferable but not absolutely required.
  • Lead auditor certification an advantage

 

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

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