Purpose of the Role

The Quality Operations Engineer is responsible for supporting, implementing, and maintaining the effectiveness of the site Quality Management System (QMS). The role ensures compliance with quality and regulatory requirements across the Donegal Libre and Blood Glucose Monitoring (BGM) manufacturing and testing operations, while driving a culture of continuous improvement and right-first-time quality.

Key Responsibilities

• Investigate, document, and support the remediation of quality issues arising within Donegal Libre and BGM operations and testing areas, ensuring timely communication and escalation as required.

• Provide quality and compliance guidance to Operations teams during product processing, manufacturing, testing, monitoring, and packaging activities.

• Act as a Quality Subject Matter Expert (SME) for Libre and BGM manufacturing processes.

• Support the ongoing monitoring, maintenance, and compliance of the Quality Management System (QMS) across operational areas.

• Plan, conduct, and review routine quality inspections in line with the site inspection programme, communicating findings and partnering with functional leaders to implement corrective and preventive actions.

• Promote a right-first-time approach to quality documentation and records by driving accountability and adherence to quality standards.

• Develop and deliver quality-related training, presentations, and toolbox talks to reinforce quality awareness and compliance across the site.

• Collect, analyse, and present quality performance metrics to support operational excellence initiatives, including Libre production processes, OpEx, Class A, and Gemba activities.

• Collaborate with cross-functional teams to identify opportunities for continuous improvement and strengthen quality performance throughout manufacturing operations.

Education and Experience

• Third-level qualification in Engineering, Manufacturing, Science, or a related discipline is preferred.

• Minimum of 2 years' experience in an Engineering, Manufacturing, Scientific, or regulated production environment, with a strong focus on Quality Operations.

• Experience working within a Quality Management System (QMS) and supporting compliance in a manufacturing environment.

• Demonstrated ability to investigate quality issues and support the implementation of corrective actions.

• Experience analysing and presenting quality performance metrics is desirable.

• Knowledge of POMS and OMD systems would be an advantage.

• Strong communication, collaboration, and problem-solving skills with the ability to influence quality-focused decision making across teams.