Quality Engineer — FDA-Regulated Manufacturing

Gi Group UK; Athlone; On-site; EUR 50,000 - 52,000; Full time

Job summary

Gi Group Ireland Limited is seeking a Quality Engineer for our Athlone site. The role focuses on maintaining and improving the Quality Management System in a regulated manufacturing environment, with emphasis on FDA compliance and ISO 13485.

You will work cross-functionally with Manufacturing, Engineering, and Regulatory teams to resolve quality issues, drive CAPA, manage NCRs, and support audits and risk assessments.

Qualifications

• Bachelor's or Master's degree in Science, Manufacturing Engineering, Biomedical Engineering, Quality or related discipline.
• 3-4 years' experience in Quality Engineering, QA or similar in regulated manufacturing.
• Experience in FDA/QMS environments and ISO 13485 knowledge.

Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS) in line with FDA requirements, ISO 13485 and relevant standards.
• Lead and support quality activities including root cause analysis, CAPA, NCRs, change control and risk management.
• Investigate NCRs ensuring effective root cause analysis and timely corrective actions.
• Support CAPA development, implementation and effectiveness monitoring.
• Assist internal and external audits including preparation, responses and follow-up actions.
• Collaborate with Manufacturing and Engineering to resolve quality issues and drive improvements.
• Support product/process risk assessments, validation, and equipment qualification.
• Review and maintain QMS documentation and quality records.

Skills

Quality engineering

CAPA

NCRs

Root cause analysis

Data analysis

Cross-functional teamwork

Education

Bachelor's or Master's in Science/Engineering

Tools

Minitab

Q-Pulse

Job description

Gi Group Ireland Limited is seeking a Quality Engineer for our Athlone site. The role focuses on maintaining and improving the Quality Management System in a regulated manufacturing environment, with emphasis on FDA compliance and ISO 13485.

You will work cross-functionally with Manufacturing, Engineering, and Regulatory teams to resolve quality issues, drive CAPA, manage NCRs, and support audits and risk assessments.