Quality Engineer – FDA/ISO 13485 Focus | CAPA & QA

Gi Group; Athlone; On-site; EUR 45,000 - 55,000; Full time

Job summary

Gi Group has a client in Athlone seeking a Quality Engineer to join a highly regulated manufacturing environment. The role focuses on maintaining and improving the Quality Management System and collaborating with cross‑functional teams across Manufacturing, Engineering and Regulatory.

The ideal candidate will have 3–4 years of experience in QA/Quality Engineering in FDA-regulated settings, with strong knowledge of ISO 13485, CAPA, NCRs and risk management.

Qualifications

• 3-4 years' experience in Quality Engineering or QA in a regulated manufacturing environment.
• Experience with FDA Quality System requirements.
• Good understanding of ISO 13485 and quality control principles.
• Strong problem-solving and analytical skills; able to drive corrective actions.

Responsibilities

• Maintain and improve the QMS in line with FDA and ISO13485 requirements.
• Lead root cause analysis, CAPA, NCRs, change control and risk management.
• Investigate NCRs and ensure timely closure with effective corrective actions.
• Support internal and external audits and prepare audit responses.
• Collaborate with Manufacturing and Engineering to resolve quality issues and drive improvements.
• Support risk assessments, process validation and equipment qualification.
• Review and maintain QA documentation and quality records.
• Assist supplier quality activities and monitor performance.
• Analyze quality data to identify trends and prevention opportunities.
• Promote a strong quality and continuous improvement culture.

Skills

Quality systems knowledge

Problem solving

Cross-functional collaboration

Attention to detail

Education

Bachelor's or Master's in Science/Engineering/Quality

Tools

Minitab

Q-Pulse

Job description

Gi Group has a client in Athlone seeking a Quality Engineer to join a highly regulated manufacturing environment. The role focuses on maintaining and improving the Quality Management System and collaborating with cross‑functional teams across Manufacturing, Engineering and Regulatory.

The ideal candidate will have 3–4 years of experience in QA/Quality Engineering in FDA-regulated settings, with strong knowledge of ISO 13485, CAPA, NCRs and risk management.