Quality Management System (qms) Specialist

Abbott

Galway, Ireland
Fully remote
Enterprise and quality management systems (eqms)
Gxp-compliant systems
Iso 13485
The QMS Specialist is responsible for supporting the delivery, maintenance, and continuous improvement of the Enterprise and Quality Management Systems (eQMS), ensuring systems align to business objectives and provide ongoing value while maintaining compliance to applicable regulations and standards

Job Summary

  • The QMS Specialist is responsible for supporting the delivery, maintenance, and continuous improvement of the Enterprise and Quality Management Systems (eQMS), ensuring systems align to business objectives and provide ongoing value while maintaining compliance to applicable regulations and standards.
  • Support users to ensure smooth day‑to‑day operation of Enterprise and Quality Systems (eQMS), maintain key system master data, and review/action user requests for system support in partnership with IT.
  • Demonstrate commitment to the development, implementation, and effectiveness of Quality Processes per ISO, FDA, and other regulatory requirements, and drive business improvements through Lean/continuous improvement initiatives and QMS metrics/KPIs management.

Matching Summary

The QMS Specialist is responsible for supporting the delivery, maintenance, and continuous improvement of the Enterprise and Quality Management Systems (eQMS), ensuring systems align to business objectives and provide ongoing value while maintaining compliance to applicable regulations and standards.

Skills & Requirements

Must-have

  • Enterprise and Quality Management Systems (eQMS)
  • GxP-compliant systems
  • ISO 13485
  • 21 CFR 820
  • Cross-functional compliance
  • Root cause analysis
  • Risk-based decision-making

Nice-to-have

  • Cloud-based SaaS solutions
  • Lean/continuous improvement initiatives
  • Global business services
  • Point-of-care diagnostics

Key Requirements

  • Bachelor’s degree in Science, Engineering, Quality, or Information Technology
  • 3+ years of experience in regulated medical device, diagnostics, or life sciences
  • Working knowledge of Quality Management System standards (ISO 13485, ISO 14971, 21 CFR 820/ISO 9001, cGMP)
  • Awareness of global regulations (FDA, CE-marking/MDR-IVDR, PMDA/PAL)
  • Strong project management and organizational skills
  • High degree of computer literacy

Work Rights

Not specified

Tailored Resume

Cover Letter