Design Quality Assurance Engineer at LGC Clinical Diagnostics (CDx) in Ballina, Ireland. This role supports the Design Control process and ensures regulatory compliance for diagnostic products, maintaining Design History Files and contributing to product development from initiation to launch. You will collaborate with R&D, Labelling, Operations, Validation, Business Development, and Supply Chain on design and change control activities, review and approve validation documentation, maintain Risk Management Files, facilitate FMEA meetings, perform Post-Market Surveillance, liaise with external customers on change requests, and train staff on design control requirements. The position requires a degree in Science/Engineering/QA or related discipline and a minimum of two years of quality experience, with knowledge of risk management and regulatory requirements for IVD/medical devices. On-site in Ballina, Ireland with a collaborative, quality-focused environment.

Design Quality Assurance Engineer at LGC Clinical Diagnostics (CDx) in Ballina, Ireland. This role supports the Design Control process and ensures regulatory compliance for diagnostic products, maintaining Design History Files and contributing to product development from initiation to launch. You will collaborate with R&D, Labelling, Operations, Validation, Business Development, and Supply Chain on design and change control activities, review and approve validation documentation, maintain Risk Management Files, facilitate FMEA meetings, perform Post-Market Surveillance, liaise with external customers on change requests, and train staff on design control requirements. The position requires a degree in Science/Engineering/QA or related discipline and a minimum of two years of quality experience, with knowledge of risk management and regulatory requirements for IVD/medical devices. On-site in Ballina, Ireland with a collaborative, quality-focused environment.