Senior Quality Engineer - Fixed Term Contract

Abbott; Galway; On-site; EUR 70,000 - 90,000; Full time

Job summary

Abbott in Ireland is seeking a Senior Quality Engineer based in Galway to support the ID Business Unit's QMS integration and continuous improvement. You will ensure compliance, lead investigations, and drive quality system enhancements across the site.

The role requires a third-level Science/Engineering degree and 5–7 years in medical devices with strong knowledge of ISO and global regulations, CAPA activity, and audit readiness. Travel ~5% may be expected.

Qualifications

• Third level qualification in Science/Engineering.
• 5–7 years in medical device industry with 5+ years in progressive roles.
• Strong knowledge of QMS and global medical device regulations (ISO9001/ISO13485/ISO14971/cGMP/CE/FDA/IVDR/MDSAP).
• Experience with problem solving and CAPA investigations.
• Audit experience would be an advantage.
• Excellent interpersonal, written and verbal communication skills.
• Pro-active attitude, excellent organization, and ability to manage multiple projects with travel ~5% annually.

Responsibilities

• Actively stays current with external and internal quality systems standards and requirements providing quality systems support.
• Possesses and applies a broad and increasing knowledge of Quality, and its application within the ID Business Unit.
• Investigate complex product quality and compliance issues (e.g. CAPA, non-conformances, audit observations), analyze data, make recommendations and develop reports.
• Identifies deficiencies in quality systems and defines systematic corrective actions. Supports the continuous improvement of quality system processes.
• Develops effective quality metrics and communicates results to key stakeholders. Preparation and maintenance of records associated with the management review process.
• Applies problem-solving skills to deal creatively with moderately complex situations and coordinates corrective actions.
• Drives compliance cross functionally in alignment with the Business Unit objectives.
• Update and create quality procedures through the change control process.
• Participate and support internal and external audits across the BU.
• Implement the CAPA system ensuring root cause analysis and corrective/preventive actions.

Skills

Interpersonal communication

Problem solving

Organizational skills

Travel ability

Education

Science/Engineering degree

Tools

MS Word

Excel

PowerPoint

Job description

Abbott in Ireland

Abbott has maintained a strong presence in Ireland since 1946 and celebrates its 80th anniversary in the country in 2026. The company supports the Irish healthcare sector with a broad portfolio spanning diagnostics, diabetes care, medical devices and nutritional products. Today, Abbott employs more than 6,500 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Abbott Rapid Diagnostics

Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions.

Purpose of the job

The Senior Quality Engineer is a member of the Quality Systems department and plays a key role in ensuring that the Quality System functions are maintained in compliance with documented procedures. The Senior Quality Engineer supports the ID (Infectious Diseases) Business Unit's QMS integration activity across the site providing guidance and expertise to ensure on-going compliance and continuous improvement. The position reports to the Quality Systems Manager and the role is based in Galway.

Major Responsibilities

• Actively stays current with external and internal quality systems standards and requirements providing quality systems support.
• Possesses and applies a broad and increasing knowledge of Quality, and its application within the ID Business Unit.
• Investigate complex product quality and compliance issues (e.g. CAPA, non-conformances, audit observations), analyze data, make recommendations and develop reports.
• Identifies deficiencies in quality systems and defines systematic corrective actions. Supports the continuous improvement of quality system processes.
• Develops effective quality metrics and communicates results to key stakeholders. Preparation and maintenance of records associated with the management review process.
• Applies problem-solving skills in order to deal creatively with moderately complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve.
• Drives compliance cross functionally in alignment with the Business Unit objective for standardization and collaboration.
• Update and create quality procedures as required through the change control process.
• Participate and support internal and external audits across the BU.
• Implement the CAPA system ensuring that comprehensive root cause analysis is completed and that corrective and preventative actions are implemented.
• Train, coach and guide lower level employees on routine procedures and processes.

Education and Competencies

• Third level qualification in Science/ Engineering
• Minimum 5-7 years of experience in medical device industry with minimum 5 years of progressively responsible positions
• Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)
• Experience with problem solving and CAPA investigations
• Audit experience would an advantage
• Excellent interpersonal, written and verbal communication skills, including ability to convey appropriate information with clarity and effectiveness.
• Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
• Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
• Able to travel internationally (approximately 5% annually)

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An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call or email