Principal Design Assurance Specialist

2 weeks ago


Galway, Galway, Ireland beBeeQuality Full time €70,000 - €95,000
Design Quality Assurance Engineer

We are seeking a talented individual to fill the role of Design Quality Assurance Engineer. As part of this team, you will be responsible for ensuring the quality of our medical devices by executing sound quality practices and maintaining an effective quality system.

The successful candidate will support the application of Design Controls in projects and provide design quality support in the resolution of quality issues.

Key Responsibilities:

  • Effective understanding of requirements and procedures that govern medical device Design Control.
  • Understanding of Design Assurance requirements to ensure project deliverables comply with all internal and regulatory requirements.
  • Develop and maintain the Product Development Process Design History File, supporting deliverables including design inputs, design outputs, design verification, design validation, useability risk management and design reviews.
  • Interface with cross-functional teams to provide technical and quality systems input.
  • Draws conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities.


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