Quality Management System (qms) Specialist

jobs.abbott

Galway, Ireland
**
Enterprise and quality management systems (eqms)
Gxp-compliant systems
Iso 13485
** Abbott is seeking a Quality Management System (QMS) Specialist to join their Galway team, responsible for maintaining and improving the Enterprise and Quality Management Systems in compliance with applicable regulations. The ideal candidate will have a strong background in regulated medical device or diagnostics environments, with a focus on quality systems and project management. **

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.
  • Demonstrate commitment to the development, implementation, and effectiveness of Quality Processes per ISO, FDA, and other regulatory requirements.
  • Drive business improvements through Lean/continuous improvement initiatives and QMS metrics/KPIs management.

Matching Summary

Match Score: 75

** Abbott is seeking a Quality Management System (QMS) Specialist to join their Galway team, responsible for maintaining and improving the Enterprise and Quality Management Systems in compliance with applicable regulations. The ideal candidate will have a strong background in regulated medical device or diagnostics environments, with a focus on quality systems and project management. **

Skills & Requirements

Must-have

  • Enterprise and Quality Management Systems (eQMS)
  • GxP-compliant systems
  • ISO 13485
  • 21 CFR 820
  • cGMP
  • Lean/continuous improvement initiatives

Nice-to-have

  • Cross-functional compliance
  • Problem-solving and data analysis
  • Cloud-based SaaS solutions
  • Working with teams across multiple time zones

Key Requirements

  • 3+ years of experience in a regulated medical device, diagnostics, or life sciences environment
  • Bachelor’s degree in Science, Engineering, Quality, or Information Technology
  • Working knowledge of recognized Quality Management System standards and practices
  • Awareness of applicable global regulations and directives
  • Demonstrated written and verbal communication, negotiation, and influencing skills
  • Strong project management and organizational skills
  • High degree of computer literacy

Work Rights

Not specified

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