Quality Assurance Manager
1 day ago
Oxford
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. 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. 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.