CAPA Engineer

Abbott Laboratories; Ireland; Remote; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Family health insurance

Life assurance

Fantastic new facility

Growing business

Job summary

Abbott Laboratories in Kilkenny, Ireland, is seeking a CAPA/QMS Engineer to facilitate and execute the CAPA process, supporting continuous improvement and risk-based prioritisation within the quality system. The role requires cross-functional collaboration, investigation, data gathering, and timely QA deliverables.

The successful candidate will work with a strong quality mindset, contribute to audits and inspections, and help ensure products meet customer needs while complying with GMP and ISO

Qualifications

• 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.
• 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

• Participate in, or lead, CAPA projects, assuring compliance, quality and timeliness of records.
• Collaborate with cross-functional teams using 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.

Skills

CAPA

Quality tools

Data analysis

Project management

Communication

Leadership

Quality systems

Education

NFQ Level 7 qualification

Tools

GMP

ISO 13485

21 CFR Part 820

Job description

Location Ireland - Kilkenny Category Quality

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 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.
• 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,
• Life assurance
• Fantastic new facility
• Growing business plus access to many more benefits.

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.

Abbott is an equal opportunities employer.

ENGINEERING INNOVATION THAT ADVANCES DIABETES CARE

We will notify you about relevant positions, and keep you in mind when we have interesting opportunities.

An Equal Opportunity Employer

Abbott is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. Employment decisions are based on qualifications, merit, and business needs.

We provide reasonable workplace accommodations. U.S. residents only: To request accommodation, please call 224-667-0340 or email [e-mail].

Abbott is committed to pay equity and transparency. Compensation is determined using objective, job-related, and gender-neutral criteria in compliance with applicable laws and local regulations.

DIVERSITY & INCLUSION

We strive to provide environments where all employees feel welcome and able to bring their full selves to work. To do this we integrate diversity, equity, and inclusion across Abbott.

SUSTAINABILITY FOR OUR FUTURE

At Abbott, sustainability means managing our efforts so we can help the greatest number of people around the world live fuller lives through better health.