Quality Engineer – FDA/ISO 13485, CAPA & Audit Expert

Gi Group UK; Athlone; Sur place; EUR 45 000 - 55 000; Plein temps

Résumé du poste

Gi Group Ireland Limited is seeking a Quality Engineer for our Athlone site. You will support the Quality Management System, drive CAPA, NCRs and change control in a regulated manufacturing environment.

The role requires 3–4 years of quality experience, strong problem-solving skills and collaboration with Manufacturing, Engineering and Regulatory teams to ensure compliance and continuous improvement.

Qualifications

• 3–4 years in Quality Engineering or Quality Assurance in a regulated manufacturing environment.
• Experience with FDA Quality System requirements and ISO 13485 awareness.
• Proven ability to perform CAPA, NCRs, root cause analysis and audits.

Responsabilités

• Maintain and continuously improve the QMS to meet FDA requirements and ISO 13485.
• Lead quality activities: root cause analyses, CAPA, NCRs, change control, risk management.
• Investigate NCRs, ensure effective corrective actions and timely closure.
• Develop and monitor CAPA and conduct internal/external audits.
• Collaborate with Manufacturing and Engineering to resolve quality issues.
• Support product/process risk assessments, validation and qualification activities.
• Review QMS documentation and quality records for compliance.
• Support supplier quality and change control activities.
• Analyze quality data/trends to identify improvements and prevent recurrence.
• Promote a strong quality culture across the organisation.

Connaissances

Root cause analysis

CAPA

NCRs

Change control

Risk management

Audits

QMS documentation

Quality data analysis

Manufacturing processes

Cross-functional collaboration

Formation

Science/Engineering degree

Outils

Minitab

Q-Pulse

Description du poste

Gi Group Ireland Limited is seeking a Quality Engineer for our Athlone site. You will support the Quality Management System, drive CAPA, NCRs and change control in a regulated manufacturing environment.

The role requires 3–4 years of quality experience, strong problem-solving skills and collaboration with Manufacturing, Engineering and Regulatory teams to ensure compliance and continuous improvement.