CAPA Engineer

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

Benefits offered by this job

Family health insurance

Excellent pension scheme

Life assurance

Job summary

Abbott Ireland requires a Quality Engineer focusing on CAPA processes to support continuous improvement within the ADC Diabetes Care division. You will work with cross-functional teams to ensure compliance, timely CAPA closure, and robust data-driven decision making.

Ideal candidates have CAPA/QA engineering experience in medical devices, with knowledge of 21 CFR Part 820, GMP and ISO 13485:2016. The role is based at Kilkenny and offers strong progression and benefits.

Qualifications

• Minimum Level 7 NFQ qualification or equivalent in a relevant discipline.
• Experience with CAPA and quality assurance/engineering.
• Prior medical device experience preferred.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, ISO 13485:2016.
• Strong communication and leadership skills in cross-functional teams.
• Advanced data analysis and statistical reporting abilities.

Responsibilities

• Participate in or lead CAPA projects ensuring compliance and timely records.
• Collaborate with cross-functional teams using Six Sigma/problem-solving methods.
• Independently investigate data and perform preliminary analysis.
• Process requests, assign owners, and ensure timely responses and approvals.
• Present status, report metrics, and identify trends and issues.
• Execute quality assurance engineering deliverables on time.
• Support CAPA training program delivery and oversight.
• Identify projects to improve quality system effectiveness and product quality.

Skills

CAPA process

Quality Assurance

Root cause analysis

Project management

Data analysis

Documentation

Communication

Medical device knowledge

Regulatory knowledge

Education

Level 7 NFQ qualification

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

WORK SHIFT

Ie - Kkyflx (Ireland)

TRAVEL

Not specified

MEDICAL SURVEILLANCE

Not Applicable

SIGNIFICANT WORK ACTIVITIES

Not Applicable