Quality Engineer

Quality Engineer

CREGG are seeking a motivated Quality 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 the medical 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 drive process improvements, maintain quality systems, and support continuous improvement initiatives.

Reporting to the Quality 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 [email protected]

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 as FMEA, 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 the Quality Management System (QMS).
• Ensure compliance with ISO 9001, ISO 13485, EU MDR, FDA, and other regulatory requirements.
• Participate in internal audits, regulatory inspections, and customer audits.
• Manage Engineering Change Orders (ECOs) and support the QPulse quality management system, including corrective actions.

Validation & Investigations

• Support process and product validations (IQ, OQ, PQ) and prepare validation documentation.
• Lead or support root cause investigations using structured methods such as 8D, 5 Whys, and Fishbone analysis.
• Review customer complaints, analyse trends, and drive corrective actions.

Supplier & Continuous Improvement

• Support supplier quality activities and investigations, including SCARs and supplier performance monitoring.
• Contribute to Lean manufacturing and continuous improvement initiatives across the site.
• Support product and process transfers from development or other manufacturing locations.

Collaboration

• 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

• Minimum 5 years’ experience in a manufacturing environment (medical device or regulated industry preferred).
• Experience working with quality systems and regulatory standards.

Education

• Level 7 or Level 8 qualification in Engineering, Quality, or a related discipline

INDTRAC