CAPA Engineer - Quality Improvement (Ireland)

Abbott Laboratories; Kilkenny; On-site; EUR 65,000 - 82,000; Full time

Benefits offered by this job

Family health insurance

Life assurance

Fantastic new facility

Growing business and benefits

Job summary

Abbott Laboratories in Kilkenny is seeking a Quality Assurance professional to lead CAPA processes and support continuous improvement of the Quality Management System. You will work with cross-functional teams to ensure compliance and timely records, while applying Six Sigma methodologies and data-driven decision making.

The role requires strong communication, project leadership, and knowledge of GMP/ISO standards, contributing to the delivery of safe, effective products from Abbott's Kilkenny

Qualifications

• Minimum Level 7 NFQ qualification or equivalent.
• CAPA and/or quality assurance/engineering experience.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485:2016.
• Strong communication and interpersonal skills.
• Proven leadership and cross‑functional project management.
• Advanced data analysis and statistical reporting skills.

Responsibilities

• Participate in or lead CAPA projects ensuring quality and timeliness.
• Collaborate with cross-functional teams using Six Sigma problem solving.
• Independently investigate, gather data, and perform preliminary analysis.
• Process requests with timely responses and approvals.
• Present status and report metrics, identify trends and issues.
• Support CAPA training program and quality system improvements.

Skills

CAPA experience

Quality Assurance

Root Cause Analysis

Quality Systems

FDA Guidelines

GMP/ISO 13485

Project Management

Data analysis

Communication skills

Education

NFQ Level 7 or equivalent

Job description

Abbott Laboratories in Kilkenny is seeking a Quality Assurance professional to lead CAPA processes and support continuous improvement of the Quality Management System. You will work with cross-functional teams to ensure compliance and timely records, while applying Six Sigma methodologies and data-driven decision making.

The role requires strong communication, project leadership, and knowledge of GMP/ISO standards, contributing to the delivery of safe, effective products from Abbott's Kilkenny