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Quality Co‑Ordinator

Production Equipment Europe · Galway

New
🇬🇧 English
EU MDR ECHA REACH RoHS

Job description

About the role

Production Equipment Europe is seeking a Quality Co‑Ordinator to join its Quality Team. Reporting to the Quality Manager, the role will manage and administer the Quality Management System across the group, supporting regulatory compliance and documentation for customers and suppliers.

Key responsibilities

  • Ensure administration of the ISO 9001 Quality Management System is compliant.
  • Support implementation and development of ISO 14001 Environmental and ISO 45001 Occupational Health & Safety systems.
  • Coordinate ESG and sustainability initiatives.
  • Liaise with customers and suppliers to obtain, provide and maintain quality and regulatory documentation, including Declarations of Conformance (EU MDR, ECHA REACH, RoHS).
  • Develop CoC templates for new products/customers and assist in generating Certificates of Conformity.
  • Prepare management review materials, track KPIs, and perform data analysis.
  • Maintain status of quarantined products and participate in internal QMS audits.
  • Support external customer and regulatory audits.
  • Perform miscellaneous duties in a fast‑paced environment.

Required profile

  • Qualification in a Quality, Science or related discipline (desirable).
  • Minimum 2 years of experience in a quality or related role within a fast‑paced environment.
  • Strong administration and analytical skills.
  • Experience working with ISO 9001:2015 and/or ISO 13485:2016.
  • Familiarity with ISO 14001 and/or ISO 45001 is a plus.

Required skills

  • ISO 9001 quality management standards.
  • ISO 13485 medical device quality standards.
  • ISO 14001 environmental management standards.
  • ISO 45001 occupational health & safety standards.
  • EU Medical Device Regulation (MDR) compliance.
  • ECHA REACH regulatory knowledge.
  • RoHS compliance understanding.

Questions fréquentes

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Published 1 week ago

Expires 1 month from now

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Production Equipment Europe

Galway