Quality Engineer: Validation, CAPA & Regulatory Compliance

HERO Recruitment; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

HERO Recruitment is seeking a motivated Quality Engineer for our Galway-based client in Ireland. You will provide quality engineering support across operational and project activities, ensuring compliance with GMP, ISO, and regulatory requirements within a regulated manufacturing environment.

You will lead investigations of quality events and CAPAs, review quality documentation, support change control, and drive continuous improvement through Lean/Six Sigma methodologies.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, or a related discipline.
• Experience in a regulated manufacturing environment (pharmaceutical, medical device, biotechnology, or similar).
• Strong documentation and analytical skills.
• Experience with CAPA, deviations, change control, and risk management.
• Familiarity with regulatory requirements (FDA, EU GMP, ISO 13485 or ISO 9001).
• Strong communication and stakeholder management.

Responsibilities

• Provide day-to-day quality engineering support to manufacturing operations.
• Investigate quality events, deviations, non-conformances, and customer complaints.
• Support root cause analysis and CAPA implementation.
• Review and approve quality documentation (procedures, work instructions, batch records).
• Support change control activities and assess quality impact.
• Monitor quality metrics and drive continuous improvement.
• Develop, review, and execute validation documentation (IQ, OQ, PQ, Process Validation).
• Support equipment, utility, and process qualification activities.
• Act as the Quality representative on cross-functional project teams.
• Support new product introductions, technology transfers, and facility upgrades.
• Review and approve project documentation from a quality perspective.

Skills

GMP knowledge

CAPA

Regulatory awareness

Quality tooling

Analytical thinking

Cross-functional collaboration

Documentation skills

Education

Bachelor's degree in Engineering, Science, Quality, or related discipline

Tools

eQMS

Job description

HERO Recruitment is seeking a motivated Quality Engineer for our Galway-based client in Ireland. You will provide quality engineering support across operational and project activities, ensuring compliance with GMP, ISO, and regulatory requirements within a regulated manufacturing environment.

You will lead investigations of quality events and CAPAs, review quality documentation, support change control, and drive continuous improvement through Lean/Six Sigma methodologies.