Connecting...

Senior Quality Engineer Design Assurance

Job description

One of the World's leading Medical Devices brands is seeking two experienced Senior Design Assurance QEs to develop ground-breaking medical and biotechnology services and devices!

Excellent salary on offer with great suite of benefits including 24 days annual leave, VHI for you and dependats or pension!

Job responsibilities: 

  • Designing change projects and developing close relationship with other quality functions.
  • Being responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction. 
  • Writing project quality plans.
  • Leading risk management activities within the project.
  • Participating within project core Teams to test protocol definition based on applicable specification and relevant requirements.
  • Reviewing and approving test protocol and reports. 
  • Assisting / conducting Failure investigations and problem-solving sessions
  • Ensuring process validation activities are completed.
  • Conducting quality functional reviews and DHF compliance reviews.

Job requirements: 

  • Level 8 degree qualified.
  • Proven expertise in design assurance including design controls and risk management (ISO 14971).
  • Experience working wth Design Histroy Files (ISO 13485).
  • Experience working in the medical device sector. 

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@sigmar.ie

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.