Quality Assurance Lead (Design Assurance)

Quality Assurance Lead (Design Assurance) EyeSpy Neuro is a New Zealand medical device company building innovative, multi-disciplinary eye-tracking technology for ophthalmic and neuro-diagnostic use. We are a small, focused team moving from development toward production, with a quality system that is aligned with ISO 13485 and FDA QMSR. This is a chance to work with world-leading researchers and scientists to build a product that improves patients’ lives, as we grow from a small, early-stage team to an established medical device company. About us EyeSpy Neuro is a New Zealand medical device company building innovative, multi-disciplinary eye-tracking technology for ophthalmic and neuro-diagnostic use. We are a small, focused team moving from development toward production, with a quality system that is aligned with ISO 13485 and FDA QMSR. This is a chance to work with world-leading researchers and scientists to build a product that improves patients’ lives, as we grow from a small, early-stage team to an established medical device company. About the role We are looking for a hands-on Quality Assurance Lead to own our quality system and be our go-to person for design control. Reporting directly to the CEO, you will keep our Design History File audit-ready, work side by side with our engineers to get compliant documentation done, and grow the quality system as we scale. What you will do Ensure our quality management system is effectively implemented and maintained in accordance with ISO 13485 and FDA QMSR and act as our liaison with certification bodies and auditors. Manage document and records control, internal and external audits, and the CAPA and nonconformance processes. Support the Design Control process, providing quality input and oversight during product design and development, and keeping the Design History File audit-ready. Manage supplier quality and monitor the activity of outsourced processes. Be responsible for establishing and delivering employee training (where applicable), maintaining records, and ensuring effectiveness of training. Help mature the quality system as we move toward production. What you will bring Essential At least three years in medical device QA under ISO 13485, with exposure to FDA 21 CFR Part 820 / QMSR. A tertiary qualification in engineering, science, or a related technical discipline, or equivalent experience. Hands-on experience maintaining a QMS (document control, audits, CAPA) and providing quality oversight of design and development. Strong documentation and communication skills, and the drive to get others over the line on schedule. Nice to have Familiarity with IEC 62304 software lifecycle documentation. Working knowledge of ISO 14971 and IEC 62366-1. Exposure to FDA 510(k) or De Novo pathways, or EU MDR. ISO 13485 internal auditor training. Experience in an early-stage or small medical device company. What we offer A genuinely hands-on role with end-to-end ownership of quality in a small, focused team building technology that matters. 10-20 hours per week A competitive salary based on your experience, plus KiwiSaver. Flexible, hybrid working in Auckland. Professional development support, and the chance to shape the quality system as we grow. The chance to be part of pioneering medical research and groundbreaking eye-tracking technology. #J-18808-Ljbffr