Quality Assurance Specialist Role

4 days ago


Bray, Wicklow, Ireland Pale Blue Dot®Recruitment Limited Full time
Quality Assurance Specialist Role

We seek a highly motivated and experienced Quality Assurance Specialist to join our team.

In this role, you will be responsible for leading and managing quality-related activities, driving excellence, and ensuring compliance with ISO 13485 and regulatory requirements.

Main Responsibilities:

  • Lead and manage root cause investigations, ensuring timely and effective CAPA implementation.
  • Develop, implement, and maintain QMS procedures and policies, ensuring adherence to ISO 13485 and regulatory requirements.
  • Conduct internal audits, identifying areas for improvement and driving quality enhancements.
  • Provide technical support for quality-related matters, ensuring compliance and process control.

Key Requirements:

  • Bachelor's degree in Engineering, Quality, or Life Sciences.
  • 3+ years' experience in a medical device or regulated manufacturing environment.
  • Proven experience with root cause analysis, CAPA management, and failure investigations.
  • Strong understanding of quality engineering tools and principles.


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