1 to 25 of 60 ISO 13485 Jobs in the UK

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 ❯

able to offer sponsorship for this post Main duties of the job The Quality & Information System Manager is responsible for the Clinical Engineering Department ISO registration and ongoing compliance as well as the databases used within Clinical Engineering. Responsible also for co-ordinating the training programmes for ISO … sites Mon-Fri, with the occasional service need to work out of hours.o To maintain comprehensive training records for clinical engineering personnel relating to ISO and the databases.o To organise and co-ordinate internal/external training programmes for clinical engineering personnel.o To assist the senior management team in … maintaining the departments database and ISO 13485 Quality Management System (QMS) ensuring all associated paperwork is maintained and current.o Main site of work is at University Hospital Lewisham, but the post holder may also be required to start work on any site used by the Trust. Travel between 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 ❯

implementation of the Business Management System (BMS), lead internal audits, support external compliance requirements, and champion best practice aligned to industry standards such as ISO 9001, ISO 13485, and AS 9100. Key Responsibilities Develop and maintain the company's Business Management System and digital platforms in line … ll Bring 3+ years of quality systems experience within a manufacturing setting (medical, aerospace, automotive, or similar). Certified or experienced internal auditor for ISO 9001, ISO 13485, or AS 9100. Excellent knowledge of quality standards and good documentation practices. Strong interpersonal and analytical skills, with a 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 ❯

to create a culture of inclusion where everyone can thrive at work and beyond. Responsibilities Ensure compliance with regulations governing Software Medical Devices including ISO 13485, ISO 27001, and ISO 62304, as well as support for the Quality Management System (QMS) Author technical documentation, and designs … for the United States and Medical Device Software for the European Union. Experience testing and validating software systems. Regulatory Affairs Certification (RAC) Devices, lead ISO13485 auditor, or equivalent. Experience working with legal/regulatory teams to translate regulatory and standard requirements to actionable engineering plans. Experience with consumer-focused software 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 ❯

holder will work on compliance activities related to Quality Management Systems and Good Manufacturing Practices. What youll do: Ensuring compliance with Quality Management Systems, ISO 9001, and GMP regulations Assisting with Quality System audits at the Bristol location Maintenance of Non Conformances and Corrective Actions system. Working closely with … Experience of working within a cGMP environment.Experience of working to EudraLex Volume 4, Part II or to 21CFR part 820. Experience of working to ISO 9001 or ISO 13485. Experienced internal auditor for ISO 9001/ISO 13485 and cGMP. Experienced in investigation of customer More ❯

CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO 13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯

CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO 13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯

CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO 13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯

CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO 13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better 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 ❯

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 ❯

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 ❯

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 ❯

system integration Contribute to the full software development life cycle, including requirements analysis, design documentation, and validation Ensure compliance with medical standards such as ISO 13485 and IEC 62304 Support verification and validation activities, including unit testing and documentation Participate in regular code reviews and technical discussions with More ❯

or support within a regulated laboratory environment. Strong lab experience is required Strong understanding of laboratory workflows, data management and compliance requirements (e.g. GLP, ISO 13485 quality systems) Hands on experience with LIMS configuration and integration with laboratory instruments and enterprise systems. Ability to analyse complex lab processes More ❯

or support within a regulated laboratory environment. Strong lab experience is required Strong understanding of laboratory workflows, data management and compliance requirements (e.g. GLP, ISO 13485 quality systems) Hands on experience with LIMS configuration and integration with laboratory instruments and enterprise systems. Ability to analyse complex lab processes More ❯

of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO 13485, FDA guidelines) is highly preferred. More ❯

of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO 13485, FDA guidelines) is highly preferred. More ❯

Prototyping : Hands-on experience with miniaturization, waterproofing, and creating robust electronics for wearable devices. MedTech Regulatory Standards : Knowledge of medical device regulatory standards (e.g., ISO 13485, FDA) and experience in compliance testing. Sensor Integration : Familiarity with various biosensor technologies, including electrochemical sensors used in wearable health devices. Wearable More ❯