Arete Medical Technologies Ltd. (“Arete”) has developed a connected diagnostic and monitoring device that measures lung mechanics and biochemical markers. The device forms the foundation for a digital health layer, for precision management of asthma, COPD, and other long-term lung conditions. These are highly impactful conditions and haven't yet had the success stories in digital health and precision medicine that heart conditions, diabetes, or cancer have. We have been successful in multiple, competitive R&D grants totalling about £2 million, including a 1.65 million Euro project that we are the lead collaborator, which had the 2nd highest score of 369 applicants from 34 countries. We value excellence, creativity, improving lives of patients, and helping clinicians do their jobs better. We are based in Cambridge UK and the role requires at least 50% (and preferably 100%) in-person working. The role will require occasional travel, mostly or entirely within the UK to conduct supplier audits. Expected to work 40 hours per week, but flexible working can be negotiated. The position will be a permanent role with a base salary in line with the local market, dependant on experience, and with potential for significant share options. We will only consider applications from candidates directly. Direct contact including a message / cover letter on why you think you are a good fit is encouraged – it will be read, and we’ll do our best to respond to all inquiries personally. Position Overview: This position is responsible for managing the QMS within Arete to ensure that the company operations are compliant with the requirements of ISO 13485:2016 and all applicable medical device regulations as referenced in the Quality Manual. The role will also become an expert on the regulatory affairs of our product, working from their own experience and with external resources/ other consultants. Ideally, the candidate will also be qualified to act as our Person Responsible for Regulatory Compliance. In the future and as we grow, the role will likely be divided with separate people taking quality and regulatory roles. Essential Duties and Responsibilities: Ensure that the processes needed for the QMS are documented, effectively implemented and remain compliant with the current requirements of ISO 13485:2016 and all associated regulatory requirements. Identify and manage improvements to the QMS required by changing standards, regulatory requirements, supplier and customer requirements. Manage and execute internal audits, except in areas for which this role is solely responsible. Host Notified Body and customer audits. Manage the supply chain: ensure that suppliers are appropriately assessed and monitored, that sub-contract manufacturer’s are complying with Arete requirements and all product related records are being completed and provided to Arete in a timely manner. Provide training to employees and contractors working on behalf of Arete to enable them to achieve the required level of competence to carry out their tasks and responsibilities. Manage the monitoring of key performance indicators for Arete to provide evidence of process and product conformity and provide data for analysis at the Management Review meetings; Act as the Management Representative for Quality. Manage the corrective and preventive action process to ensure that non-conformities are identified and appropriately addressed to prevent recurrence and improvements are effectively introduced into the business. Manage all Post Market Surveillance, Fields Safety Corrective Action and Field Safety Notice activities including communication with and reporting to Competent Authorities. Provide a point of contact for customers with regard to Quality and Regulatory matters. Qualifications/Competencies/Position Requirements: Knowledge, Skills, and Abilities: Good understanding of the requirements of ISO 13485, UK MDR, EU MDD and EU MDR and proven ability to develop and maintain the QMS. Experience with medical device manufacturing and associated supporting process and record keeping. Excellent interpersonal, communication and training skills. Experienced ISO 13485 Auditor, or able to be trained towards the same. Good data analysis and presentation skills. Highly developed organizational skills and ability to prioritize, plan and execute improvement projects. A competent self-manager, able to motivate self and others. Experience or formal training (preferred), or ability to learn the following standards: o IEC 60601-1, with 60601-1-2 and 60601-1-11 (electrical safety) o ISO 10993 and 18562 (biocompatibility) o Lung function standards and guidelines (ERS/ATS, ISO 26782) Higher Education and Experience: At least 5 years’ experience working in a Quality role in a medical device design/ manufacturing business with responsibility for managing the QMS. Preference to candidates with experience working around at least one electronic measurement medical device. ISO 13485:2016 Lead Auditor qualified preferred, but Internal Auditor qualification accepted, or ability to be trained towards the same and ability to work under the supervision of an external consultant with the formal qualifications. Preferably have hosted, alone or jointly, Notified Body or customer audits. Familiarity with regulatory processes for reporting adverse events and managing device recalls/field safety corrective actions. Familiarity with software as a medical device would be a benefit.