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Senior Quality Engineer - Sterilisation

Job description

Quality Engineer – Sterilisation

Work with one of the world’s largest medical device companies on product excellence and design development projects at the forefront of device innovation and patient care. There will be several NPI projects where this person will develop and validate new and existing processes and procedures. 

Responsibilities: 

  • Act as site lead for all sterilisation activities
  • Work on product excellence, focusing on sterility assurance for NPD projects and site transfers
  • Provide expertise on design protocols, ensuring a smooth transition for change controls and ensuring compliance to all regulatory standards
  • Partner with product development project teams to develop strong working relationships for manufacturing and design teams and projects
  • Act as Sterilisation SME on internal and external audits, advising on submissions or answering questions from notified bodies
  • Lead root cause analysis and continuous improvement activities
  • Implement best practice with respect to validations and laboratory test methods

 Requirements: 

  • Level 8 degree within STEM discipline and 4 years or more experience in quality engineering or sterility
  • Should be experienced in sterilisation or biocompatibility

 

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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