CAPA Engineer

Thornton Tomasetti; Kilkenny; On-site; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Family health insurance

Pension scheme

Life assurance

Career development

New facility

Job summary

Abbott Kilkenny is seeking a Quality Assurance/Engineering professional to drive CAPA activities and maintain the QMS on site.

You will partner with cross-functional teams to ensure compliance, timely records, and lead improvement projects; support audits and training programs to sustain product quality.

The role emphasizes data analysis, problem solving, and collaboration across departments in a manufacturing setting in Ireland.

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.
• 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

• 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.

Skills

CAPA experience

Quality assurance

Project management

Communication skills

Data analysis

FDA/ISO knowledge

Education

NFQ Level 7 or equivalent

Bachelor's degree in a relevant discipline

Tools

Minitab

Excel

Job description

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.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.

Abbott is an equal opportunities employer. 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: ADC Diabetes Care LOCATION: Ireland > Kilkenny : Kilkenny Business and Technology Park ADDITIONAL LOCATIONS: WORK SHIFT: Ie - Kkyflx (Ireland) TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott is about the power of health.

For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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