Medical Device Software Quality Engineer

Location: Ireland/UK based role working from home. Regular collaboration with global teams across the U.S., Europe, and Canada Right to Work: Candidates must be based in and have the right to work in Ireland . We are unable to offer Irish visa sponsorship for this role. About this Role: The Medical Device Software Quality Engineer reports to the Quality and Regulatory Affairs Manager, supporting software quality for medical device product development, day-to-day Quality Management System (QMS) operations to ISO 13485:2016 and MDSAP requirements, and assisting with regulatory compliance activities for medical software (including AI-assisted diagnostic tools) primarily in the US and Canadian markets. Responsibilities: Software Quality for product development Software lifecycle & AI model governance: Software Testing oversight: Own QA oversight of testing activities by reviewing and approving strategies, plans, and reports for software and AI verification and validation, ensuring adequate coverage of safety‑critical and AI‑critical functions, bias/robustness checks, and complete, audit-ready test documentation. Support validation activities for software and processes: assist in the preparation of IQ/OQ/PQ documentation, test protocols and validation reports for IVD software and regulated tools used in US and Canadian GxP environments. Provide QA oversight across the full software and AI model lifecycle (requirements, design, implementation, V&V, release, maintenance), en