Quality Assurance Expert

5 days ago

Galway, Galway, Ireland beBeeQuality Full time €90,000 - €120,000
Design Quality Assurance Engineer

Our organization is committed to advancing science for life, transforming lives through innovative medical solutions that improve patient outcomes and create value for customers.

The Design Quality Assurance Engineer will play a key role in demonstrating commitment to quality by executing sound quality practices and maintaining an effective quality system.

This role supports the application of Design Controls in projects, initially supporting a Product Development Process (PDP) project.

Key Responsibilities:

  • Effective understanding of requirements and procedures governing medical device Design Control.
  • Understanding of design assurance requirements to ensure project deliverables comply with all internal and regulatory requirements.
  • Develop and maintain the PDP Design History File, supporting deliverables including design inputs, design outputs, design verification, design validation, useability risk management and design reviews.
  • Provide design quality support in the resolution of product issues, process deviations, and regulatory requirement changes.
  • Interface with cross-functional teams to provide technical and quality systems input.
  • Draw conclusions and make appropriate decisions from test data using excellent analytical and problem-solving abilities.
  • Ownership of design change projects including scoping, assessment and implementation.
  • Drive updates to documents within the Risk Management File, such as the Hazard Analysis, Task and Use Error Analysis and Design FMEA.
  • Ensure and maintain regulatory compliance with applicable guidance documents.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

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