Quality Compliance Coordinator

2 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €50,000 - €75,000

We are seeking a Quality Assurance Specialist to join our team in Dublin, Ireland.

">Job Description

The successful candidate will play a key role in ensuring ongoing compliance with quality, regulatory, and safety standards. This includes contributing to documentation, process improvements, and audits, as well as supporting the transition to MDR compliance under EN ISO 13485.

The role is responsible for fostering a culture of quality, continuous improvement, and process ownership across the site. Key responsibilities include:

  1. ">
  2. Providing technical and administrative support to operations for QMS documentation
  3. Monitoring and reporting in-process results and quality KPIs
  4. Supporting the QESH team in the transition to the MDR, including in-house testing, documentation and practical assistance.
  5. Auditing and ensuring ongoing compliance with QMS standards and site quality practices.
  6. Managing employee training, including training records, gap analysis, and QESH-related training initiatives.
  7. Acting as the interface between Quality Assurance, Customer Care and Operations.
  8. Leading and supporting customer complaint investigations, NCs, CAPAs
  9. Maintaining process documentation and coordinating updates
  10. Driving lean initiatives and root cause problem-solving through methodologies such as RCCM, 5 Whys, Ishikawa, A3, and 8D.
  11. Assisting in product spec development and change management
  12. Delivering onboarding and ongoing training sessions
  13. Managing hazardous chemicals control on site
  14. Participating in internal/external audits and ensuring audit readiness
  15. Developing and executing test protocols with regulatory-compliant reporting

Requirements

We are looking for someone with a minimum 3 years' QC experience in a regulated Medical Device or Pharmaceutical environment. The ideal candidate should have a strong understanding of EN ISO 13485, ISO 9001, and the Medical Devices Regulation (MDR). Experience in compliance, risk management, and regulated QC practices is essential. A primary degree in a scientific discipline, or equivalent experience, is required. Strong communication and organizational skills, as well as the ability to work independently and collaboratively, are also essential.

Benefits

This is a full-time position based in Fonthill, Dublin. Monday to Friday, standard office hours apply.

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