CAPA Quality Engineer – Medical Devices

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

Benefits offered by this job

Health insurance

Pension

Life assurance

Career development

New facility

Benefits access

Job summary

Abbott Ireland in Kilkenny is seeking a Quality Assurance engineer to drive CAPA processes and maintain the QMS. You will assess risks and prioritise activities to ensure effective CAPA management.

You will collaborate with cross-functional teams, conduct investigations, and ensure timely CAPA closure while supporting audits and training. The role requires a Level 7 NFQ qualification, medical device experience, and strong analytical and communication skills.

Qualifications

• Minimum Level 7 NFQ qualification or equivalent in a relevant discipline.
• 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

• Lead or participate in CAPA projects ensuring compliance, quality, and timeliness.
• Collaborate with cross-functional teams using Six Sigma root-cause analysis and problem solving.
• Independently investigate data and perform initial analyses.
• Manage requests, assign owners, and secure timely approvals.
• Present status, report metrics, and identify trends or issues.
• Deliver QA engineering outputs on time.
• Support CAPA training program delivery.
• Identify projects to improve quality system and product quality.
• Assist Operations with quality/compliance decisions during processing and packaging.
• Ensure site delivers safe, compliant products meeting customer needs.

Skills

CAPA experience

Quality assurance engineering

Project management

Data analysis

Communication skills

Education

NFQ Level 7 qualification or equivalent

Job description

Abbott Ireland in Kilkenny is seeking a Quality Assurance engineer to drive CAPA processes and maintain the QMS. You will assess risks and prioritise activities to ensure effective CAPA management.

You will collaborate with cross-functional teams, conduct investigations, and ensure timely CAPA closure while supporting audits and training. The role requires a Level 7 NFQ qualification, medical device experience, and strong analytical and communication skills.