Quality Engineer

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

Location: Athlone, Co. Westmeath

Salary: €50,000 per annum

Experience: 3-4 years

About the Role

Our client, a leading organisation within the regulated manufacturing sector, is seeking a motivated and experienced Quality Engineer to join their team in Athlone.

This is an excellent opportunity for a Quality Engineer with 3-4 years of experience to develop their career within a highly regulated manufacturing environment. The successful candidate will support the maintenance and continuous improvement of the Quality Management System while working closely with Manufacturing, Engineering, Regulatory and other cross-functional teams.

The ideal candidate will have a strong understanding of quality systems, problem-solving methodologies and manufacturing processes, together with practical experience working within an FDA-regulated environment.

Key Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS) in compliance with FDA requirements, ISO 13485 and applicable standards and regulations.
• Lead and support quality activities including root cause analysis, CAPA, NCRs, change control and risk management.
• Investigate Non-Conformance Reports (NCRs), ensuring effective root cause analysis, corrective actions 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, equipment qualification and other quality-related manufacturing activities.
• Review and maintain QMS documentation, including procedures, work instructions, inspection records and associated quality records.
• Support supplier quality activities, including supplier issues, corrective actions and quality performance monitoring.
• Support change control activities for product and process changes, ensuring quality requirements are addressed.
• Analyse quality data and trends to identify improvement opportunities and prevent recurring issues.
• Promote a strong quality and continuous improvement culture across the organisation.

Qualifications & Experience

• 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.
• Previous experience within a regulated industry, preferably medical device manufacturing, is highly desirable.
• Practical experience with FDA Quality System requirements.
• Good understanding and practical application of ISO 13485.
• Experience with CAPA, NCRs, root cause analysis, change control, risk management and audits.
• Strong problem-solving and analytical skills, with the ability to investigate quality issues and implement effective corrective actions.
• Good understanding of manufacturing processes and quality control principles.
• Strong attention to detail with the ability to manage multiple quality activities effectively.
• Excellent communication and interpersonal skills with the ability to work effectively across cross-functional teams.

The following would be considered advantageous but are not essential:

• Knowledge or experience of EU MDR requirements.
• Knowledge of SPC, statistical analysis and quality improvement methodologies.
• Experience with process validation and equipment qualification.
• Exposure to supplier quality management.
• Experience working within cleanroom or controlled manufacturing environments.
• Lean Six Sigma or other recognised quality-related qualifications.
• Experience using quality and data analysis software such as Minitab, Q-Pulse or equivalent systems.

KSGalway

Should you require any support or assistance, please contact your local Gi Group office.

Gi Group Ireland Limited are acting as an Employment Agency in relation to this role.

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