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Principle Quality Engineer

Job description

Principle Quality Engineer

  • You will Co-ordinate and drive the sterilisation, biocompatibility and environmental monitoring programs onsite, training quality inspectors on sterile release and driving increased approval and compliance.
  • Drive and develop annual objectives and site compliance in relation to ISO11135, ISO10993, ISO14644, ISO11607, ISO13485, FDA QSR and DMR.
  • Review and improve product and paperwork preparation for sterilisation and environmental monitoring in manufacturing.
  • With customer and product quality in mind, analyse data and suggest potential improvements, developing set processes for the site.
  • Oversee validation for sterilisation onsite.
  • Lead FDA, NSAI, Customer and Corporate audits regarding sterilisation documentation and process.
  • Ensure and manage continuous improvement and compliance projects, stemming from trend analysis or customer reports. This will mainly relate to sterilisation validation standards and biocompatibility standards.
  • Will need good working knowledge of Sterilisation Cycle.
  • Will work with the R&D team to ensure the customer specifications are met and all the testing is correct.

 

Requirements

  • Engineering or science degree, qualification in microbiology is preferable.
  • Six sigma qualifications desirable.
  • 1-3 years’ experience in a quality assurance and sterilization role.

  

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

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