1 to 25 of 54 ISO 13485 Jobs in the UK

system (QMS) ensuring compliance with regulatory requirements and supporting regulatory submissions. The successful candidate should have a strong background in regulatory standards such as ISO 13485, to ensure quality and regulatory adherence in our product development and implementation. They should have experience managing the QMS, conducting internal and … external audits and implementing CAPA processes to drive continuous improvement. A solid understanding on risk management (ISO 14971), validation (IQ, OQ, PQ) and GCLP principles is essential. The candidate must possess strong problem-solving skills, attention to detail, the ability to work autonomously and have excellent interpersonal skills to … person, at least 3 times a week, during typical working hours. This role will also require occasional travel owing to international lab setup. Responsibilities ISO 13485 compliance and quality management system (QMS) maintenance Ensure full compliance with ISO 13485:2016 standards. Oversee, manage and improve the More ❯

Software Engineer, Quality, IEC 62304, ISO 13485, Medical Devices, COR7184 A rare and exciting opportunity has arisen for a Software Engineer with experience working with software as a medical devices and IEC 62304 standards, to join a pioneering scientific R&D company specialising in the development of medical … Diagnostic products. Working alongside a highly skilled team, you'll be responsible for implementing and maintaining SDLC processes, software risk management, and compliance with ISO 13485, IEC 62304, and 21 CFR Part 820. This is a fantastic opportunity to make a significant impact in a fast-growing company … Engineer? Experience defining, implementing, and maintaining Software Development Life Cycle (SDLC) processes Proven experience in software quality engineering and risk management Strong knowledge of ISO 13485, IEC 62304, 21 CFR Part 820, IVDR Experience in software security risk management (SW:96:2023, ISO 27001, IEC 80001) is More ❯

supporting their commitment to quality, compliance, and continuous improvement, helping to safeguard the integrity of their products and processes. Drawing on your expertise in ISO 17025 and wider regulatory frameworks, you will take ownership of their Business System Manuals and Technical Documentation, ensuring they remain robust, up to date … and audit ready. As the Management Representative for ISO 13485:2016, you will lead internal audits, monitor regulatory changes, and drive compliance initiatives across the business, working closely with teams to embed quality and regulatory best practices into everything they do. Whether maintaining technical documentation, leading management reviews … of all in-vitro diagnostic medical devices manufactured and sold by our client and manage all technical documentation. To act as management representative for ISO 13485:2016. Requirements for this role: Demonstrable experience of ISO 17025 accreditation within a laboratory environment. Experience of ISO 9001, ISO More ❯

Quality Assurance Engineer - Medical Device (MDR ISO 13485) Location : Leeds Salary: Up to £50,000 Are you a passionate and detail-oriented Quality Assurance professional with an interest in working on a complex medical device? We are seeking a dedicated Quality Assurance Engineer to become the expert in … edge medical device while receiving training to thrive in the position. Key Responsibilities: Oversee the implementation and adherence to MDR (Medical Device Regulation) and ISO 13485 in the development of medical devices. Ensure all quality assurance processes align with the latest medical regulation requirements, focusing on MDR compliance. … Create and manage standard operating procedures (SOPs), documentation, and reports in line with 13485 standards. Conduct regular audits, inspections, and testing of medical devices to ensure they meet both MDR and ISO 13485 requirements. Support the creation and maintenance of documentation related to regulatory submissions and quality More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

the deployment of updates, new features, and issue resolution Implement ITIL best practices, including incident, problem, change, and knowledge management processes Ensure compliance with ISO 27001, ISO 13485, GDPR, and the NHS Data Security & Protection Toolkit Monitor and maintain the performance, health, and security of internal and … for a range of hardware including PCs, laptops, tablets, and mobile devices (Android/iOS) - Cloud experience (AWS preferred) - Comfortable working in and supporting ISO-regulated environments (ISO 27001/ISO 13485) Desirable Skills: - Experience within the healthcare sector, ideally with exposure to NHS IT systems More ❯

and Goods Inwards. Assist in day to day running of the customer RMA process. Preparing PPAP and FAIR reports. Assisting in maintaining ISO9001, and ISO 13485 Quality management standards. Carrying internal audits as per ISO 9001 and ISO 13485 standards. Assist in supplier quality assurance … problem solving methods like 8D, fishbone, 5Whys, etc. Practical experience of PFMEA, Process Maps and Quality Control Plans. Experience in PPAP and FAIRs. Internal ISO 9001 auditor Demonstrable people and project management skills. Able to understand the basics of technical drawings, measurements, and tolerances. Experienced with using MS Excel … Willing to learn from mistakes and handle constructive criticism positively. Significant advantages Experience in electronic manufacturing, particularly PCB manufacturing. Experience with ISO14001 Experience with ISO13485 Experience with ISO 27001. Lead ISO 9001 auditor Six-sigma green belt Lean manufacturing Qualifications Essential A suitable college-level qualification (A-level More ❯

An interest in healthcare, software, or quality/compliance - A degree (or equivalent), or relevant experience in administration, finance, or customer support - Experience with ISO-certified systems (such as ISO 13485, ISO 27001, or ISO 9001) is desirable This role might particularly suit someone with More ❯

seeking to recruit an experienced Quality Systems Engineer to complement their professional Quality Division. Reporting to the Quality Manager and working in an ISO9001, ISO13485, ISO14001 and IATF16949 accredited environment based near Dudley, the successful candidate will be tasked with developing the Quality strategy, policies, processes, standards and systems within … knowledge of quality and business systems and strong knowledge of APQP, PPAP and FMEA, along with Lean Manufacturing/Six sigma and ITAF 16949, ISO 13485, ISO 9000, gained within a high volume manufacturing environment. You will demonstrate a good understanding of engineering drawings and manufacturing processes … measurement and quality assurance, with knowledge of both ISO 27001 and ISO14001 and Health and Safety Practices gained in an automotive environment proving distinctly advantageous. Contact the Quality Team at Premier Technical Recruitment on 01827 68400 or email your cv in confidence to for further details. More ❯

highest quality standards in our production processes. Key Responsibilities: Conduct internal audits of manufacturing processes, documentation, and quality control systems to ensure compliance with ISO 13485, FDA regulations, and other applicable standards. Prepare and maintain audit reports, documenting findings, non-conformances, and corrective actions. Work with quality and … best practices. Qualifications & Experience: Proven experience as a Quality Systems Engineer/Quality Assurance Engineer in a medical devices manufacturing environment. Strong knowledge of ISO 13485, FDA regulations, and GMP. Experience conducting internal and external audits. Excellent analytical skills with attention to detail. Strong communication and reporting skills. More ❯

with IoT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc). Experience of working within a Quality System ideally EN ISO 13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience : Degree in Electronics Engineering. At least More ❯

Experience with IOT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc) Experience of working within a Quality System ideally EN ISO 13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience : Degree in Electronics Engineering. At least More ❯

the release process. Ensure compliance with regulatory or internal change management policies, including experience with standards surrounding software as a medical device, for example ISO 13485 and ISO 62304. Test Automation Maintain best practices for release management, such as CI/CD (Continuous Integration/Continuous Deployment More ❯

and reliable medical devices. Responsibilities: Software Development: Design and develop software for medical devices while ensuring compliance with industry standards such as IEC 62304, ISO 14971, IEC 62366, ISO 13485, and FDA regulations, including cybersecurity requirements. Implementation & Compliance: Develop software solutions and support cross-functional development activities More ❯

the technical deliverables. Conduct functional and non-functional testing. Software development is to be undertaken in accordance with industry standards and working within an ISO 13485 quality management system relevant to a class 2b device under IEC 62304, IEC (phone number removed) and IEC (phone number removed) Person More ❯