Sr. Associate Quality Systems Specialist

MGI McKesson Global Sourcing Limited [Irish Branch]

📍 Cork, County Cork, Ireland

Full time Business Operations Specialists

Job Description

About the Role

McKesson Medical-Surgical is seeking a Senior Quality Systems Specialist to support our Quality Management System (QMS) and ensure compliance with medical device regulations and international quality standards. This role is responsible for processing customer complaints, maintaining quality records, supporting audits, administering document control activities, and contributing to continuous improvement initiatives.

The ideal candidate will bring experience in quality assurance within the medical device, pharmaceutical, or regulated healthcare industry and possess a strong understanding of ISO 13485, FDA regulations, CAPA processes, and quality system documentation.

What You'll Do

Quality Systems & Compliance

  • Maintain and process quality records within the electronic Quality Management System (eQMS), including complaints, CAPAs, deviations, nonconformances, and change controls.
  • Ensu...
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