Connecting...

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

Responsibilities: 

  • 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

 

Requirements: 

  • 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:   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

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.