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Quality engineer

Galway
CREGG
Quality engineer
Posted: 12 March
Offer description

CREGG are seeking a motivatedQuality Engineer to join our established Quality team on a Permanent basis. This is an excellent opportunity to develop your career within a growing company that manufactures products for themedical technology, ICT, and agri-technology sectors.
In this role, you will support manufacturing operations by ensuring products, processes, and systems meet internal quality standards and regulatory requirements. You will work closely with Operations, Engineering, and Supply Chain teams to driveprocess improvements, maintain quality systems, and support continuous improvement initiatives.
Reporting to theQuality Manager, you will also collaborate with the wider Quality team, including Quality Inspectors, Incoming Inspectors, and the Quality Technician.
For more information contact Mark: 086 190 1346 or markhalligan@cregg.ie
Key Responsibilities
Process & Product Quality

Provide responsive Quality Assurance support to manufacturing operations.
Drive process improvements to enhance product quality, yield, and process reliability.
Identify opportunities for risk reduction, error-proofing, automation, and cost improvement.
Apply quality tools such asFMEA, DOE, SPC, and CpK analysis to monitor and improve process performance.
Track and analyse key quality metrics to identify trends and improvement opportunities.

Quality Systems & Compliance

Support the implementation and continuous improvement of theQuality Management System (QMS).
Ensure compliance withISO 9001, ISO 13485, EU MDR, FDA, and other regulatory requirements.
Participate ininternal audits, regulatory inspections, and customer audits.
Manage Engineering Change Orders (ECOs) and support theQPulse quality management system, including corrective actions.

Validation & Investigations

Supportprocess and product validations (IQ, OQ, PQ) and prepare validation documentation.
Lead or supportroot cause investigationsusing structured methods such as8D, 5 Whys, and Fishbone analysis.
Review customer complaints, analyse trends, and drive corrective actions.

Supplier & Continuous Improvement

Support supplier quality activities and investigations, includingSCARs and supplier performance monitoring.
Contribute toLean manufacturing and continuous improvement initiativesacross the site.
Support product and process transfers from development or other manufacturing locations.
Provide technical support and guidance to members of the Quality team.
Work cross-functionally with Operations, Engineering, and Supply Chain on quality and improvement projects.

Qualifications & Experience
Experience

Minimum5 years’ experiencein a manufacturing environment (medical device or regulated industry preferred).
Experience working withquality systems and regulatory standards.

Education

Level 7 or Level 8 qualificationin Engineering, Quality, or a related discipline

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