CAPA Engineer - Drive Quality & Continuous Improvement

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

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.