Quality Engineer - QMS, CAPA & FDA/ISO 13485 Expert

Gi Group Holding; Athlone; On-site; EUR 50,000 - 55,000; Full time

Job summary

A Quality Engineer position in Athlone, Ireland, is available to support the maintenance and continual improvement of the Quality Management System in line with FDA and ISO 13485 standards.

You will lead CAPA and NCR activities, assist with audits, and collaborate across Manufacturing and Engineering to drive process improvements and risk management. A degree in a relevant field and 3–4 years of quality engineering experience are required.

Qualifications

• Bachelor's or Master's degree in Science, Manufacturing Engineering, Biomedical Engineering, Quality or a related discipline.
• 3-4 years' experience within Quality Engineering, Quality Assurance or a similar role in a regulated manufacturing environment.
• Experience with FDA Quality System requirements and ISO 13485 awareness.
• Experience with CAPA, NCRs, root cause analysis, change control, risk management and audits.

Responsibilities

• Support the maintenance and continuous improvement of the QMS in compliance with FDA requirements, ISO 13485 and applicable standards.
• Lead and support quality activities including root cause analysis, CAPA, NCRs, change control and risk management.
• Investigate NCRs and ensure effective root cause analysis and timely closure.
• Support CAPA development, implementation and effectiveness monitoring.
• Support internal and external audits, including preparation, audit responses and follow-up actions.
• Collaborate with Manufacturing and Engineering teams to resolve quality issues and drive continuous process improvement.
• Support product and process risk assessments, process validation and equipment qualification.
• Review and maintain QMS documentation including procedures and work instructions.
• Support supplier quality activities including supplier issues and corrective actions.
• Support change control activities for product and process changes.
• Analyze quality data and trends to identify improvement opportunities.
• Promote a strong quality and continuous improvement culture.

Skills

Root cause analysis

CAPA

NCRs handling

Audits

Analytical skills

Communication

Risk management

Cross-functional teamwork

Problem solving

Education

Bachelor's or Master's degree in Science, Manufacturing Engineering, Biomedical Engineering, Quality or a related discipline

Tools

Minitab

Q-Pulse

Job description

A Quality Engineer position in Athlone, Ireland, is available to support the maintenance and continual improvement of the Quality Management System in line with FDA and ISO 13485 standards.

You will lead CAPA and NCR activities, assist with audits, and collaborate across Manufacturing and Engineering to drive process improvements and risk management. A degree in a relevant field and 3–4 years of quality engineering experience are required.