Quality Manager
6 days ago
Bath
Salary: £50,000 – £55,000, depending on experience Location: Science Creates St Philips, Bristol Working pattern: Full time, 37.5 hours per week, on-site About Us Carbometrics is a Bristol-based chemistry company specialising in the design and synthesis of highly selective binding molecules for use in cutting-edge sensors across hospitals, medical devices, bioprocessing, and industrial applications. Our mission is to help people with diabetes and other conditions live longer, more comfortable lives by improving real-time monitoring of key analytes such as glucose. Built on over 20 years of pioneering research from Professor Anthony Davis' group at the University of Bristol, our proprietary Biomimetic Glucose Binding Molecules (GBM) underpin a glucose sensing platform capable of delivering a market-leading Continuous Glucose Monitor (CGM). The same core technology, developed through our predecessor company Ziylo, was acquired by Novo Nordisk to develop smart insulins. We have since expanded into a broader analyte portfolio including potassium, lactate, pH, CO2, and calcium, building toward the most comprehensive continuously monitored sensor array for medical use. We're based at Science Creates, Bristol's leading scientific incubator and ecosystem, working alongside a highly motivated team of scientists. Role Overview Carbometrics is introducing an ISO 13485 Quality Management System (QMS) to support the development and manufacture of our products. We are looking for a Quality Manager to lead this process, establishing, embedding and owning the QMS from the ground up, and building the foundations of a quality function that will scale with the company. This is a hands-on, high-ownership role for someone who enjoys building something new, is comfortable working independently and alongside external consultants as the sole quality specialist in a small team, and wants to shape how quality is done as we grow toward regulatory submission and product launch. What You'll Be Doing Core responsibilities: • Own the introduction and ongoing maintenance of the company's ISO 13485 QMS, including document control, record-keeping and change control, • Define, implement and continuously improve quality processes, procedures and forms appropriate to a growing start-up, in collaboration with the wider team, • Chair management review meetings and ensure all assigned actions are completed, • Plan and lead the internal audit programme, and lead preparation for and hosting of external audits, supplier audits, certification and notified body assessments, • Own the non-conformance, CAPA and root-cause investigation process, ensuring timely and effective resolution and tracking of trends, • Manage supplier and vendor qualification, quality agreements and quality-related supplier performance, • Act as the main point of contact for quality matters with external suppliers, contractors, auditors and, as the company grows, notified bodies or regulators, • Support the science and engineering teams with QC testing, incoming inspection of materials, and routine data review Additional responsibilities: • Maintain a strong safety and quality culture, including timely reporting and investigation of incidents, non-conformances and learning events, • Report on quality performance and QMS status to the leadership team, recommending priorities for continuous improvement, • Keep procedures up to date as the company, product portfolio and QMS mature, • Build strong working relationships across a small, cross-functional team as a trusted advisor on quality and compliance, • Help define and build out the quality function as the company grows, including identifying where additional resource is needed, • Contribute ideas to improve personnel safety, environmental performance and process quality What You'll Bring Qualifications: • BSc in an appropriate scientific or engineering discipline (e.g. Life Sciences, Chemistry, Biomedical or Chemical Engineering), or equivalent, • Further qualification or equivalent practical experience in quality management, e.g. MSc in Quality Management, or a recognised quality certification (e.g. ISO 13485/9001 lead auditor training) Essential skills and experience: • Proven experience implementing and/or managing a QMS in a regulated environment, ideally ISO 13485, ISO 9001 or an equivalent standard (e.g. IATF 16949, AS9100), • Experience owning document control, record-keeping and change control processes, and generating and maintaining quality documentation (SOPs, work instructions, risk assessments, forms) to a high standard, • Experience planning and leading internal audits, and preparing for and hosting external audits or certification assessments, • Experience managing non-conformances, root-cause investigations and CAPAs through to effective closure, • Strong numeracy, literacy and computer skills, with close attention to detail and accuracy in written work, • Proficiency in MS Office (Excel, Word, PowerPoint, SharePoint), • Ability to work independently as the sole quality specialist, using sound judgement to solve problems and work with ambiguity as new processes are established, • Significant experience in a practical laboratory or manufacturing environment, in academia and/or industry, including standard health and safety practices, • Strong stakeholder management and communication skills, with the ability to influence quality culture across a cross-functional science and engineering team Desirable skills and experience: • Familiarity with ISO 13485:2016, including its application to a start-up or first-time device manufacturer, • Experience with QC testing of samples and processes (e.g. routine characterisation of incoming reagents and standards) and reviewing associated data, • Experience with routine maintenance, calibration and qualification of instrumentation and equipment, • Awareness of the medical device Product Development Process and associated standards, e.g. ISO 14971 (risk management), IEC 62304 (software), IEC 62366 (usability), • Awareness of ISO 10993 for biocompatibility, • Experience acting as, or supporting, a Management Representative role, or preparing a company for its first regulatory or notified body assessment What's On Offer • Salary of £50,000 – £55,000, depending on experience, • The opportunity to build and lead the quality function as the company scales, • A base at Science Creates, Bristol's leading scientific incubator, working alongside a motivated team of scientists, • The chance to shape how quality is done at a company working on market-leading glucose sensing technology Additional Information The candidate must be authorised to live and work in the UK. This role is expected to be office-based five days a week. Closing date for applications is 6th October 2026, unless the role is filled earlier. Carbometrics values diversity and is an equal opportunities employer, welcoming applicants who meet the requirements of the role regardless of gender, ethnic origin, disability, age, religion or sexual orientation. REF-230 099 JBRP1_UKTJ
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