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Senior Quality Engineer Process Validation

Job description

Senior Quality Engineer Process Validation – 9 months  

In this job, you will provide validation support from initial development right through to when the products have been commercialized. You will be part of a cross-functional team.

 

What you will do:

  • Provide expert QE technical guidance to qualification and validation activities, collaborating with other Engineering & QA teams
  • Document and provide support of qualification/validation protocols/reports
  • Have a strong understanding of product design & functionality at a highly competent level to contribute to decision making process on product acceptance standards
  • Lead & support others in root cause investigations; drive problem solving initiatives for quality issues

 

What you will need:

  • Bachelors’ degree (Level 8 NFQ) in Engineering/ Science and desirably with a minimum of 5 years relevant experience.
  • Knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements and ISO 13485 requirements is necessary.
  • Knowledge of combination products, statistical requirements or software validation requirements an advantage.

 

What you will receive:

  • Competitive Salary & Comprehensive Benefits Package, Training & Development

 

 

To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@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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