Quality Engineer

Galway
Permanent
Full-time

1 month ago

Our client are looking for a Quality Engineer to join their team in Galway. The successful candidate will join an established Quality team and will have the opportunity to further develop their career within a company who manufacture products for the medical technology, ICT, and agri-technology sectors. The Quality Engineer will support manufacturing operations by ensuring that processes, systems and products meet internal quality standards and regulatory requirements. The role will focus on process improvement, quality systems, regulatory compliance, and continuous improvement initiatives, while providing strong technical quality support to operations. The position reports to the Quality Manager and works closely with operations, engineering, and supply chain teams, while supporting the wider quality team including Quality Inspectors, Incoming Inspectors and the Quality Technician.Key Responsibilities

Provide proactive Quality Assurance support to Operations to ensure product quality, cost and output targets are achieved.
Drive process improvements to enhance yield, reduce risk, minimise complaints and support process automation.
Monitor and analyse key quality metrics using statistical tools (SPC, CpK) to identify trends and improvement opportunities.
Support and maintain the site Quality Management System (QMS) ensuring compliance with ISO 9001, ISO 13485, EU MDR and FDA requirements.
Participate in internal audits, regulatory inspections and customer audits.
Manage engineering changes, validations (IQ/OQ/PQ) and quality documentation in line with regulatory requirements.
Investigate customer complaints, supplier issues and quality deviations, driving root cause analysis and corrective actions.
Support supplier quality management, including SCARs and supplier performance monitoring.
Lead and support Lean and continuous improvement initiatives across the site.
Collaborate with Operations, Engineering and Supply Chain to drive quality improvements and support product/process transfers.
Provide technical guidance and coaching to quality team members.

Education and Experience

5 years + in a manufacturing or medical device environment.
Experience working within regulated manufacturing environments is highly desirable.
Level 7 / Level 8 qualification in Engineering, Quality or related discipline.
Strong understanding of Quality Engineering tools and methodologies.

Experience with statistical techniques and process capability analysis.
Hands-on experience with Lean Manufacturing or continuous improvement initiatives.
Familiarity with ISO 9001 and ISO 13485 quality management systems.
Knowledge of EU MDR regulations would be highly advantageous.

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