Abbott in Galway serves as the international hub for Abbott's Rapid Diagnostics business, delivering more than 2 billion tests annually across various healthcare settings
Job Summary
Abbott in Galway serves as the international hub for Abbott's Rapid Diagnostics business, delivering more than 2 billion tests annually across various healthcare settings.
The QMS Specialist is responsible for supporting the delivery, maintenance, and continuous improvement of the Enterprise and Quality Management Systems, ensuring compliance with applicable regulations and standards.
This role involves partnering with IT and business stakeholders to deliver validated solutions on time and budget, driving compliance, and facilitating root cause analysis and effectiveness checks for quality-related issues.
Matching Summary
Abbott in Galway serves as the international hub for Abbott's Rapid Diagnostics business, delivering more than 2 billion tests annually across various healthcare settings.
Skills & Requirements
Must-have
Enterprise and Quality Management Systems (eQMS)
GxP-compliant systems experience
ISO 13485 and FDA regulatory compliance
Cross-functional compliance with QMS processes
Cloud-based SaaS solutions proficiency
Risk-based decision-making
Project management and organizational skills
Nice-to-have
User training and documentation development
Lean and continuous improvement initiatives
Experience with global regulations and directives
Working across multiple time zones
Strong communication and negotiation skills
Key Requirements
Bachelor’s degree Level 8 or higher
3+ years in regulated medical device or diagnostics environment
Experience with ISO 13485, ISO 14971, 21 CFR 820, cGMP
Awareness of FDA, CE-marking/MDR-IVDR, PMDA/PAL regulations