Quality Engineer at Athlone, Westmeath

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.

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Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Ireland Limited and Kelly Services (UK) Ltd. Gi Group Ireland Limited are acting as an Employment Agency in relation to this role.

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