We are partnering with a medical device company in Oxford, based in the Magdalen Centre, Littlemore, developing a culture-free in vitro diagnostics platform for rapid bacterial identification and antimicrobial susceptibility testing direct from whole blood. The technology integrates Raman spectroscopy, spiral microfluidics separation, and machine learning-driven spectral analysis to deliver clinically actionable results in a fraction of the time required by conventional blood cultural workflows. This is a hands-on, foundational QA role. You will join a small, highly skilled multidisciplinary team and be responsible for designing, implementing, and sustaining an ISO 13485-compliant QMS from an early-stage baseline. You will work directly with engineering, software, clinical, and operations teams to embed quality processes across the product development lifecycle; including design controls, risk management, software validation, and tool qualification. About the Role QMS Development pragmatic in approach, and able to coach colleagues at all levels on quality practices without being prescriptive. Problem solver who is open to constructive challenge with a good continuous improvement mindset. Desirable Requirements Experience in an early-stage startup or spin-out environment where QMS infrastructure did not previously exist. Experience with IEC 62304 (medical device software lifecycle) and / or IEC 62366 (usability engineering). Exposure to engineering tool qualification or laboratory instrument validation. Degree in a relevant scientific, engineering, or quality discipline (or equivalent professional experience). Lead auditor qualification to ISO 13485:2016.
Quality Assurance Manager
