Quality Engineer

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

Job summary

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.

Responsibilities

• 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.

Skills

Root cause analysis

CAPA

NCRs

Change control

Risk management

Audits

QMS documentation

Quality data analysis

Manufacturing processes

Cross-functional collaboration

Education

Science/Engineering degree

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.

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

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