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 /

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