Quality Assurance Specialist

1 week ago


Bray, Wicklow, Ireland beBeeQuality Full time €35,000 - €40,000
Job Description

We are seeking a diligent and detail-oriented Quality Assurance Specialist to support our clients' quality assurance team.

The ideal candidate will ensure compliance across the Quality Management System (QMS) in accordance with ISO 13485, IVDR (EU 2017/746), and other applicable regulatory standards.

  • Oversee the upkeep and revision of Quality Management System (QMS) documentation, including standard operating procedures, work instructions, and associated records.
  • Contribute to the development and ongoing support of processes aligned with IVDR requirements.
  • Organise and manage internal and external audits, including planning, documentation handling, and follow-up on corrective actions.
Required Skills and Qualifications
  • Strong administrative capabilities.
  • Ideal experience in a quality or regulatory capacity within the IVD or medical device sector.
  • Working knowledge of ISO 13485, IVDR, and ISO 14971 standards.
Benefits
  • Full-time permanent role.
  • Competitive benefit package.
Others
  • Highly collaborative and supportive environment.
  • Opportunities for growth and professional development.


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