Quality Engineer

Job description

High Flying start-up – Quality Engineer

Work within a small quality team of three under an ambitious Quality Manager within a fast growing and very interested start-up company within Galway


  • Conduct and lead process validation and risk management to ensure regulatory compliance, utilising statistical techniques
  • Develop process validation protocols in conjunction with manufacturing
  • Support supplier quality activities such as qualification, assessment and audit process of key suppliers
  • Generate and complete NCRs and CAPAs, ensuring effective closure
  • Manage sterilization activities including documentation and product release
  • Establish, define and maintain incoming, in-process & final inspections requirements
  • Support design and validation testing
  • Manage change requests
  • Support QMS activities including internal audits



  • Must have a degree in science, biomedical engineering or quality management with 2 years or more experience in quality engineering or a similar position
  • Knowledge of Medical Device Quality Management System Requirements ISO 13485, MDD 93/42 EEC, 21 CFR Part 820, CMDR


To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:  

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