Quality Manager
7 days ago
Bristol
Carbometrics is a Bristol-based chemistry company designing and synthesising highly selective binding molecules for cutting-edge sensors used in hospitals, medical devices, bioprocessing and industry. Our mission is to help people with diabetes and other conditions live longer, more comfortable lives through better real-time monitoring of analytes such as glucose. \n Built on over 20 years of 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've since expanded into potassium, lactate, pH, CO and calcium, building toward the most comprehensive continuously monitored sensor array for medical use. \n We're based at Science Creates, Bristol's leading scientific incubator, alongside a highly motivated team of scientists. \n Role Overview \n Carbometrics is introducing an ISO 13485 Quality Management System (QMS) to support the development and manufacture of our products. As Quality Manager, you'll establish, embed and own the QMS from the ground up, building the foundations of a quality function that scales with the company. \n This hands-on, high-ownership role suits someone who enjoys building something new, is comfortable working independently and with external consultants as the sole quality specialist in a small team, and wants to shape how quality is done as we move toward regulatory submission and product launch. \n What You'll Be Doing \n\n • Own the introduction and maintenance of our ISO 13485 QMS, including document control, record-keeping and change control\n, • Define, implement and improve quality processes, procedures and forms suited to a growing start-up, working with the wider team\n, • Chair management review meetings and ensure actions are completed\n, • Plan and lead the internal audit programme, and lead preparation for and hosting of external, supplier, certification and notified body audits\n, • Own the non-conformance, CAPA and root-cause investigation process, ensuring timely resolution and tracking trends\n, • Manage supplier and vendor qualification, quality agreements and supplier quality performance\n, • Act as main quality contact for suppliers, contractors, auditors and, as we grow, notified bodies or regulators\n, • Support science and engineering teams with QC testing, incoming material inspection and routine data review\n, • Maintain a strong safety and quality culture, including timely reporting and investigation of incidents, non-conformances and learning events\n, • Report on quality performance and QMS status to leadership, recommending improvement priorities\n, • Keep procedures up to date as the company, products and QMS mature\n, • Build strong relationships across a small, cross-functional team as a trusted advisor on quality and compliance\n, • Help build out the quality function as we grow, identifying where more resource is needed\n, • Contribute ideas to improve personnel safety, environmental performance and process quality\n\n What You'll Bring \n Qualifications: \n\n • BSc in a relevant scientific or engineering discipline (e.g. Life Sciences, Chemistry, Biomedical or Chemical Engineering), or equivalent\n, • Further qualification or equivalent experience in quality management, e.g. MSc in Quality Management or ISO 13485/9001 lead auditor training\n\n Essential skills and experience: \n\n • Proven experience implementing and/or managing a QMS in a regulated environment, ideally ISO 13485, ISO 9001 or equivalent (e.g. IATF 16949, AS9100)\n, • Experience owning document control, record-keeping and change control, and producing high-quality documentation (SOPs, work instructions, risk assessments, forms)\n, • Experience planning and leading internal audits, and preparing for and hosting external audits or certification assessments\n, • Experience managing non-conformances, root-cause investigations and CAPAs through to effective closure\n, • Strong numeracy, literacy and computer skills, with close attention to detail\n, • Proficiency in MS Office (Excel, Word, PowerPoint, SharePoint)\n, • Ability to work independently as the sole quality specialist, using sound judgement and handling ambiguity as new processes are established\n, • Significant practical laboratory or manufacturing experience, in academia and/or industry, including standard health and safety practices\n, • Strong stakeholder management and communication skills, with the ability to influence quality culture across a science and engineering team\n\n Desirable skills and experience: \n\n • Familiarity with ISO 13485:2016, including its application to a start-up or first-time device manufacturer\n, • Experience with QC testing of samples and processes (e.g. characterising incoming reagents and standards) and reviewing the data\n, • Experience with maintenance, calibration and qualification of instruments and equipment\n, • Awareness of the medical device Product Development Process and standards such as ISO 14971 (risk management), IEC 62304 (software) and IEC 62366 (usability)\n, • Awareness of ISO 10993 for biocompatibility\n, • Experience acting as or supporting a Management Representative, or preparing a company for its first regulatory or notified body assessment\n\n What's On Offer \n\n • The opportunity to build and lead the quality function as the company scales\n, • A base at Science Creates, working alongside a motivated team of scientists\n, • The chance to shape quality at a company developing market-leading glucose sensing technology\n\n Additional Information You must be authorised to live and work in the UK. This role is office-based five days a week. \n Closing date for applications is 6th October 2026, unless the role is filled earlier. \n 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. \n REF - 230 099
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