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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 & Maintenance Conduct a gap analysis of the current QMS against ISO 13485:2016 requirements and define a roadmap to fully implementation Evaluate, select, and implement an electronic Quality Management System (eQMS) appropriate for an early-stage IVD company intending to scale at speed Author, review, release, and maintain the full suite of ISO 13485-required SOPs and work instructions Prepare the organisation for, and act as internal lead during, Notified Body audits, FDA inspections and other audits performed by external parties
Staff Training & Compliance Design, implement and deliver role-appropriate QMS training for all staff, ensuring documented competency records within the eQMS. Develop and maintain an ongoing training programme as operating procedures are updated or new procedures are introduced. Monitor and report on training completion and compliance status to senior leadership. Act as the internal subject matter expert and first point of contact for all quality-related questions from staff.
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Internal Audit & Continuous Improvement Establish and conduct an internal audit programme against ISO 13485 requirements. Own end-to-end NC, CAPA, and complaint processes through to effective closure. Conduct root cause investigations and monitor CAPA effectiveness. Drive CAPA processes and track effectiveness through to closure. Report quality KPIs and QMS health metrics to leadership on a regular cadence.
Documentation, Design and Development Setup and own the document control system including version control, approval workflows, retention, access controls Deliver training and provide support to colleagues for QA and document control activities Ensure design and development procedures are ISO:13485 compliant, and that work instructions aligned with current organisational practices. Also ensure records are maintained throughout the product lifecycle. Provide QA review and sign-off on design documents, risk assessments, test plans, and verification / validation reports. Ensure each product maintains compliance with the Design and Development procedures
Supplier and Quality Management Qualify suppliers, maintain a Supplier List, and conduct supplier audits. Manage quality agreements and conduct periodic supplier performance reviews. Establish product and production control procedures incorporating quality control and release activities in preparation of design transfer of the prototype into product manufacturing
Software, Design and Development Tool Validation Lead or provide hands-on QA input into Computer System Validation (CSV) activities for development tools Define validation strategies, author Validation Plans, IQ/OQ/PQ protocols, and Validation Reports. Maintain a validated state for all quality-critical software tools and ensure re-validation is triggered appropriately on system changes.
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About the Candidate Essential Requirements Demonstrable experience (≥5 years) implementing or managing an ISO 13485-compliant QMS within a hardware focussed medical device or IVD environment. Strong working knowledge of ISO 13485:2016, ISO 14971, EU IVDR, and FDA 21 CFR Part 820. Hands-on experience authoring and releasing operating procedures, work instructions, and quality management records. Experience delivering QMS training and building a culture of quality in a small team. Practical experience with eQMS platforms – including evaluation, configuration, and rollout. Understanding of Computer System Validation (CSV) / software validation principles (IQ / OQ / PQ) with the ability to author and execute validation plans, protocols and reports. Ability to operate independently, prioritise in a fast-moving startup environment, and communicate quality concepts clearly to non-QA colleagues. Confident integrating into a multidisciplinary team of scientists, engineers, and clinicians; 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.
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