Company Description Astratus Limited, a University of Reading spin-out company, is revolutionising microbiology laboratory methods with its innovative technology. Its rapid, accurate, and high-throughput laboratory platform significantly reduces turnaround times and lowers labour requirements. Focused on antimicrobial stewardship, the system enables precise treatment of urinary tract infections, helping combat antimicrobial resistance. Astratus serves human, veterinary, and research markets with its novel microcapillary cassette and instrument reader platform for antimicrobial susceptibility testing (AST). The platform provides reliable, scalable digital AST results under six hours, supporting both clinical and research applications. Role Description This is a full-time, on-site role for a Quality Systems Coordinator, based in Reading. The role involves ensuring compliance with ISO 13485 and other relevant regulatory standards for in vitro diagnostic (IVD) medical devices. Key responsibilities include managing quality system documentation, supporting quality audits, overseeing quality control procedures, coordinating the implementation of quality assurance processes, and supporting regulatory submissions. The role also requires collaboration with cross-functional teams to maintain and improve the Quality Management System (QMS). Qualifications Proficiency in Document Management and maintaining technical and quality documentation Experience with Quality Auditing and supporting internal and third-party audits Knowledge of Quality Control processes and techniques for ensuring product integrity Familiarity with Quality Management and adherence to ISO 13485 standards Expertise in the implementation and continuous improvement of QMS Strong organisational, analytical, and problem-solving skills Familiarity with in vitro diagnostic (IVD) devices is an advantage Bachelor’s degree in a scientific, technical, or related discipline ideal