CAPA Engineer

Abbott; Kilkenny; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Pension

Life assurance

Career development

New facility

Benefits access

Job summary

Abbott Ireland in Kilkenny is seeking a Quality Assurance engineer to drive CAPA processes and maintain the QMS. You will assess risks and prioritise activities to ensure effective CAPA management.

You will collaborate with cross-functional teams, conduct investigations, and ensure timely CAPA closure while supporting audits and training. The role requires a Level 7 NFQ qualification, medical device experience, and strong analytical and communication skills.

Qualifications

• Minimum Level 7 NFQ qualification or equivalent in a relevant discipline.
• CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.
• Prior medical device experience preferred.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485:2016.
• Solid communication and interpersonal skills.
• Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.

Responsibilities

• Lead or participate in CAPA projects ensuring compliance, quality, and timeliness.
• Collaborate with cross-functional teams using Six Sigma root-cause analysis and problem solving.
• Independently investigate data and perform initial analyses.
• Manage requests, assign owners, and secure timely approvals.
• Present status, report metrics, and identify trends or issues.
• Deliver QA engineering outputs on time.
• Support CAPA training program delivery.
• Identify projects to improve quality system and product quality.
• Assist Operations with quality/compliance decisions during processing and packaging.
• Ensure site delivers safe, compliant products meeting customer needs.

Skills

CAPA experience

Quality assurance engineering

Project management

Data analysis

Communication skills

Education

NFQ Level 7 qualification or equivalent

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 Diabetes Care Kilkenny

Abbott Diabetes Care has opened a new site, in Kilkenny, that is at the forefront of Diabetes care with the latest technology, to manufacture Freestyle blood glucose test strips and Freestyle Sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the Freestyle Precision, Freestyle Lite and Freestyle Libre systems.

MAIN PURPOSE OF THE ROLE

Responsible for facilitating and executing to the CAPA process. Support the continuous improvement and effective maintenance of the QMS Ensure the use of appropriate risk management tools to prioritise activities and the level of effort required.

MAIN RESPONSIBILITIES

• Participate in, or lead, the completion of CAPA projects, assuring compliance, quality and timeliness of records.
• Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).
• Independently investigate, gathers data, and perform preliminary analysis.
• Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
• Present and communicate status, report metrics, identify trends potential issues, improvement initiatives, as applicable
• Execute and provide on-time completion of Quality Assurance engineering deliverables.
• Support team in the delivery and oversight of CAPA training program.
• Responsible for identifying projects to enhance and promote the effectiveness and efficiency of the quality system and product quality.
• Support Operations to make Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring and packaging
• Ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance
• Provide support and subject matter expertise during audits and inspections.

Qualifications & Experience

• Minimum Level 7 NFQ qualification or equivalent in a relevant discipline
• Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.
• Prior medical device experience preferred.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485:2016.
• Solid communication and interpersonal skills.
• Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.

What we Offer

Attractive compensation package that includes competitive pay, as well as benefits such as

• Family health insurance,
• Excellent pension scheme
• Life assurance
• Career Development
• Fantastic new facility
• Growing business plus access to many more benefits.

Important Information

Please note that any offer of employment is conditional upon the successful completion of a pre-employment medical examination, including drug and alcohol screening, conducted by a Company-designated medical practitioner.

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Abbott is an equal opportunities employer.

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