Senior Quality Engineer

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: 
The Senior Quality Engineer is responsible for supporting and executing strategic initiatives across the full spectrum of quality systems, including complaint handling, CAPA, audit readiness, document control, and regulatory compliance. This role integrates expertise in quality assurance, project execution, and business analysis to deliver compliant, efficient, and value-driven solutions that align with organizational goals and regulatory requirements. 

Main Responsibilities

• Coordinate cross-functional efforts across Quality, IT, and other business units to implement and maintain robust quality system processes. 
• Ensures compliance to ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements. 
• Support the development, enhancement, and maintenance of enterprise-wide quality applications, including complaint handling, CAPA, audit management, and document control. 
• Manage project scope, timelines, risks, and resources to ensure successful execution of quality-related initiatives. 
• Analyze business needs and translate them into actionable project plans, system requirements, and process improvements. 
• Conduct stakeholder reviews to prioritize system enhancements and ensure alignment with business and regulatory objectives. 
• Monitor project performance and communicate progress through reports and dashboards to stakeholders and leadership. 
• Apply risk assessment and problem-solving techniques to resolve complex quality and system issues. 
• Support internal and external audits, perform gap analyses, and lead implementation of compliance improvements. 
• Investigates, and resolves quality system nonconformance’s (defined during internal and/or external audits. 
• Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements 
• Promote a culture of continuous improvement and regulatory excellence across all quality system domains. 

Knowledge, Skills & Experience

• Bachelor’s degree in engineering, Life Sciences, or related field. 
• 5+ years of experience in Quality Assurance and Project Management within a regulated industry. 
• Strong knowledge of ISO 13485, 21 CFR 820, and global quality systems. 
• Proven experience managing cross-functional projects and delivering results. 
• Excellent analytical, problem-solving, and decision-making skills. 

Preferred: 

• Experience with enterprise quality systems (e.g., Salesforce, TrackWise, Agile). 
• PMP or Six Sigma certification. 
• Familiarity with enterprise platforms and system implementation. 
• Strong communication and stakeholder engagement skills. 

The base pay for this position is

N/A

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

     

JOB FAMILY:

Operations Quality

DIVISION:

ID Infectious Disease

LOCATION:

Ireland > Galway : Parkmore East Business Park

ADDITIONAL LOCATIONS:

WORK SHIFT:

Ie - 39.0Hst2 (Ireland)

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable