JOB DESCRIPTION:

About Abbott

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 114,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott in Ireland

Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

Abbott Galway

Abbott in Galway serves as the international hub for Abbott's Rapid Diagnostics business, which delivers annually more than 2 billion tests. As the global leader in point-of-care diagnostics, Abbott offers the broadest portfolio of best-in-class rapid tests, services, and handheld devices across all healthcare settings: the lab, the clinic, remote healthcare outposts, retail outlets, the patient's bedside and at home. Our industry-leading near patient tests and services are unmatched across key health and therapeutic areas, including: infectious disease, cardiometabolic & informatics, toxicology and consumer diagnostics.

One of the key functions in Galway is Global Business Services, which provides number of shared services activities across finance, purchasing, quality, technical and customer services for Europe, Middle East and Africa (EMEA). Various global and EMEA commercial and operational management teams across our infectious disease and cardiometabolic businesses are also based in Galway, overseeing the supply of millions of rapid tests from HIV to diabetes to COVID-19, to patients in many regions across the world.

Position Summary

Rapid & Molecular Diagnostics Division (RMDx) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams and industry‑leading technologies to support diagnostic testing. 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.

Essential Duties and Responsibilities

• Support users to ensure smooth day‑to‑day operation of Enterprise and Quality Systems (eQMS).
• Maintain key system master data to enable correct processing and reporting.
• Review, disposition, and action user requests for system support in partnership with IT Run/Support teams.
• Identify business needs and recommend compliant, risk‑based solutions that support strategic decision‑making.
• Collect and prioritize requests for system enhancements; coordinate release planning with Business Unit stakeholders and IT.
• Partner with IT to deliver validated solutions on time and on budget; perform effectiveness checks and capture lessons learned.
• Liaise between internal customers and IT during preliminary installation, validation, and testing of new features and functionality.
• Act as system Subject Matter Expert (SME): design and deliver user training; maintain procedures, work instructions, and job aids.
• Demonstrate commitment to the development, implementation, and effectiveness of Quality Processes per ISO, FDA, and other regulatory requirements.
• Drive cross‑functional compliance with QMS processes (document control, training, change control, audits, CAPA, risk management).
• Serve as an escalation point for quality‑related nonconformances and CAPAs; facilitate timely root cause analysis and effectiveness checks.
• Apply problem‑solving and data analysis techniques to interpret complex or ambiguous issues; use risk‑based decision‑making.
• Support complaint handling and post‑market surveillance trending processes in collaboration with quality engineering teams.
• Support internal/external audits and inspections; maintain audit readiness and coordinate responses and corrective actions.
• Drive business improvements through Lean/continuous improvement initiatives and QMS metrics/KPIs management.

Education / Experience / Skills

• Bachelor’s degree (Level 8 or higher) in Science, Engineering, Quality, or Information Technology.
• 3+ years of experience in a regulated medical device, diagnostics, or life sciences environment; experience with GxP‑compliant systems.
• Working knowledge of recognized Quality Management System standards and practices (e.g., ISO 13485, ISO 14971, 21 CFR 820/ISO 9001, cGMP).
• Awareness of applicable global regulations and directives (e.g., FDA, CE‑marking/MDR‑IVDR, PMDA/PAL).
• Demonstrated written and verbal communication, negotiation, and influencing skills; ability to interact effectively across functions and levels.
• Strong project management and organizational skills with a proven track record of delivering KPIs in a changing environment.
• High degree of computer literacy, including experience with cloud‑based SaaS solutions/eQMS and proficiency in MS Word, Excel, and PowerPoint.
• Ability to work with teams across multiple time zones as needed.

Preferred Qualifications

• 5+ years of experience in quality systems within a regulated industry.
• Hands‑on experience administering or supporting eQMS modules (Document Control, Training, Change Control, CAPA, Audits, Risk Management).
• Experience leading cross‑functional investigations, risk assessments, and continuous improvement projects.

The base pay for this position is

N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Customer Service

DIVISION:

ID Infectious Disease:

LOCATION:

Ireland > Galway : Parkmore East Business Park

ADDITIONAL LOCATIONS:

WORK SHIFT:

Ie - 37.5Hst0 (Ireland)

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Not Applicable