1 to 25 of 48 ISO 13485 Jobs in the UK

Manufacturers. Your responsibilities: Get authorised to audit and certify the quality management systems of the most innovative healthcare companies in the world Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.) Optimise the assessment of customer data by designing efficient audit processes Be involved in maintaining … equivalent Work experience - Minimum of four years of professional experience in the field of medical devices Work experience - Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971, etc.) Work experience - Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU MDR, ISO 14971, etc. … demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security, and one or more programming languages Desirable skills: Work experience - Experience working with ISO 27001 Analytical reader - You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information Ferociously curious - You like going down rabbit holes, understanding More ❯

opportunity for a Quality Assurance Manager to join them on a permanent basis. As their new QA Manager, you will be responsible for leading Quality Assurance, ensuring compliance with ISO 13485, FDA 21 CFR Part 820 and other applicable international regulations. This is a key leadership role, managing the QA team, driving a culture of compliance, and ensuring … strategic and operational quality objectives. Key Responsibilities Lead and develop the QA team, managing performance, training, and mentoring. Maintain and continually improve the Quality Management System in compliance with ISO 13485, FDA QSR, EU MDR and other applicable standards. Oversee internal and external audits, including hosting regulatory inspections. Manage CAPA, NCR, and root cause analysis processes, ensuring timely … monitoring. Experience and Skills Required 5+ years of Quality Assurance experience within the Medical Device sector. Minimum of 2 years in a managerial or leadership role. Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820 and EU MDR. Experience hosting regulatory inspections and leading internal audits. Proven leadership skills with the ability to influence More ❯

Engineer. In this role you will play a key part in our Quality Team, reporting to the Head of Quality, responsible for the maintenance of the quality system to ISO 13485 standards and associated product certification. As a Quality Systems Engineer, you will: Support the maintenance and continuous improvement of our ISO 13485 compliant Quality Management … audits. Analyse quality data and contribute to process improvement initiatives. Required experience: 2+ years of experience in a Quality role within the medical device industry Hands-on knowledge of ISO 13485 and 21 CFR 820 Strong attention to detail and problem solving skills Ability to work as part of a multi-disciplinary, fast-paced diverse team Ability to More ❯

to the wider company. Awareness of the sensitive nature of our data - following our data protection guidelines. Being fully aware of our ways of working - within our regulatory standards (ISO 13485, ISO 27001). ️ We want to hear from you if you Have experience in the following tech stack: Frontend: React, State Management, React Native (optional but … with Publish-Subscribe pattern Experience of working with Jira, BitBucket and Git Experience in working within a regulated SDLC process (optional but advantageous) Experience in working in MedTech, including ISO 62304 (optional but advantageous) Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality More ❯

manage a career development framework. Own IEC 62304 traceability, architecture documentation, and release quality for critical features and audits. Establish agile delivery practices that work within the constraints of ISO 13485 and MDR/FDA expectations. Introduce best engineering & delivery practices, improve and and report on velocity, release cadence, defect rate, and other metrics. Champion continuous improvement - lead … paced, regulated medical or AI-based software environment, having delivered multiple health tech products Building and delivering clinical software products with end-to-end traceability under IEC 62304 and ISO 13485 Driving complex technical decision-making (e.g., architecture reviews, release criteria) Leading or supporting regulatory audits and inspections Managing stakeholders across Engineering, Product, QA, and Compliance Implementing metrics … team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our More ❯

manage a career development framework Own IEC 62304 traceability, architecture documentation, and release quality for critical features and audits Establish agile delivery practices that work within the constraints of ISO 13485 and MDR/FDA expectations Introduce best engineering & delivery practices, improve and and report on velocity, release cadence, defect rate, and other metrics Champion continuous improvement lead … paced, regulated medical or AI-based software environment, having delivered multiple health tech products Building and delivering clinical software products with end-to-end traceability under IEC 62304 and ISO 13485 Driving complex technical decision-making (e.g., architecture reviews, release criteria) Leading or supporting regulatory audits and inspections Managing stakeholders across Engineering, Product, QA, and Compliance Implementing metrics … team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our More ❯

working with the Lead to align on deliverables and be key in delivering to multiple business units. Being fully aware of our ways of working - within our regulatory standards (ISO 13485, ISO 27001). ️ We want to hear from you if you Have experience in the following tech stack: Backend: Nodejs, JavaScript, Express Frontend: React, (optional but … and HL7 Ability to deal with internal and external stakeholders. Good communication skills. Collaborative and willing to listen to others ideas. Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our More ❯

maintain firmware for embedded systems using STM32 microcontrollers Implement and optimise RTOS (FreeRTOS) and embedded communication protocols (Bluetooth BLE, I2C) Ensure compliance with relevant industry standards including IEC 62304 & ISO 13485 Collaborate with cross-functional teams including hardware, software, and regulatory Lead firmware reviews, debug issues, and drive performance and reliability improvements Maintain clear and thorough documentation across … Bluetooth BLE and serial communication protocols (e.g. I2C) Experience building firmware that interfaces with iOS/Android via BLE Knowledge of regulated environments and applicable standards (e.g. IEC 62304, ISO 13485) Familiarity with CI/CD pipelines, automated testing, and embedded cybersecurity This is a great opportunity for an experienced embedded systems engineer join a fast-growing MedTech More ❯

maintain firmware for embedded systems using STM32 microcontrollers Implement and optimise RTOS (FreeRTOS) and embedded communication protocols (Bluetooth BLE, I2C) Ensure compliance with relevant industry standards including IEC 62304 & ISO 13485 Collaborate with cross-functional teams including hardware, software, and regulatory Lead firmware reviews, debug issues, and drive performance and reliability improvements Maintain clear and thorough documentation across … Bluetooth BLE and serial communication protocols (e.g. I2C) Experience building firmware that interfaces with iOS/Android via BLE Knowledge of regulated environments and applicable standards (e.g. IEC 62304, ISO 13485) Familiarity with CI/CD pipelines, automated testing, and embedded cybersecurity This is a great opportunity for an experienced embedded systems engineer join a fast-growing MedTech More ❯

that to be considered for this role you must have the right to work in this location. Responsibilities: Oversee and manage a quality management system (QMS) that complies with ISO 13485 standards. Handle document control, change management, corrective actions, training records, audits, and supplier oversight. Lead internal and external audits, ensuring systems are always ready for inspection. Develop … marking, MHRA Class I-II, FDA registration, and 510(k) processes. Maintain technical files and coordinate cross-functional inputs to meet regulatory deadlines. Key Skills and Requirements: Experience managing ISO 13485-compliant QMS and leading audits. Familiarity with Software as a Medical Device (SaMD) is essential. Strong knowledge of UKCA, MHRA, FDA regulations, and cybersecurity standards such as More ❯

like medical devices, consumer electronics, or automotive. Strong knowledge of quality systems, tools, and methodologies (e.g., Six Sigma, Lean, FMEA, SPC). Experience with regulatory compliance and standards (e.g., ISO 9001, ISO 13485, FDA QSR). Excellent analytical, problem-solving, and communication skills. Proven leadership and project management abilities. Desirable Skills & Experience: Certified Quality Engineer (CQE). … Six Sigma Green/Black Belt. ISO Lead Auditor Certification. If you meet the qualifications and are excited about the opportunity to contribute to a progressive and innovative organisation, please submit your CV for consideration. Our client offers a stimulating work environment, flexible working options, and attractive benefits for the right candidate. Note: Due to the nature of this More ❯

code from general requirements. 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 3-5 years of industrial experience in More ❯

to proactively identify and mitigate risks. Work closely with the security team to integrate best practices into new and existing features. Ensure compliance with security standards and regulations (e.g., ISO 27001, SOC 2). Implement monitoring solutions to detect and respond to real-time security incidents. Troubleshoot infrastructure and security issues, performing root cause analysis in production. Mentor junior … cloud platforms (AWS, GCP). Experience with security tools like OWASP ZAP, Burp Suite, etc. Familiarity with Jira, Confluence, or similar tools. Knowledge of compliance frameworks (e.g., GDPR, HIPAA, ISO 27001, ISO 13485). Background in start-up or scale-up environments is a plus. Key Attributes: Strong collaboration skills. Eagerness to learn and upskill in new More ❯

STM32). Familiarity with RTOS, bare-metal, or embedded Linux environments. Professional experience utilising Docker containers. Experience with communication protocols (UART, SPI, I2C, USB). Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820. Strong understanding of software development lifecycle and version control (e.g., Git). Qualifications Bachelor's or Master's degree in computer More ❯

work as part of a multi-disciplinary team DESIRABLE REQUIREMENTS: Use of schematic capture software Circuit analysis experience Knowledge of simulation packages Mathematical analysis skills Experience working within an ISO13485 or similar quality system Experience following IEC 62304 or similar Development of test harnesses and tools using C#/.NET. More ❯

tools and environment. Suggests changes to current Optos systems to improve efficiency and quality of software development. All activities to be carried out in compliance with the Optos SDLC, ISO13485 and FDA Medical Device Design Control processes. MINIMUM QUALIFICATIONS Educated to degree level in a software engineering discipline or equivalent education gained through work experience. 5+ years' experience in designing More ❯

level driver development. Strong understanding 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 ❯

level driver development. Strong understanding 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 ❯

embedded, application, and UI layers. Own our full software stack - from real-time firmware to intuitive user interfaces. Introduce lean, agile development practices within a regulated framework (IEC 62304, ISO 13485). Build for extensibility - enabling third-party instrument development and open platform integrations. Collaborate cross-functionally with hardware, UX, clinical, regulatory, and quality teams. Manage and mentor … track record delivering full-stack systems, including RTOS-based firmware and application software. Deep knowledge of modular, scalable platform architecture. Strong grasp of compliance standards like IEC 62304 and ISO 13485. Excellent communication, problem-solving, and team-building skills. Experience leading teams and delivering in dynamic, mission-driven environments. Your Background: Degree-qualified in software engineering, computer science, electrical … engineering, or related discipline. Bonus points for direct experience with IEC 62304 or ISO 13485. Willingness to travel occasionally for labs or customer collaboration. Why Join Us? This is a rare opportunity to own the software backbone of a system with global clinical impact. At Creo, you'll help define the digital infrastructure powering the future of surgery - with More ❯

product development efforts, focusing on expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO 13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and troubleshooting. Duties and Responsibilities Assist … wide range of molecular biology reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers’ technical support activities. Hands-on More ❯

product development efforts, focusing on expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO 13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and troubleshooting. Duties and Responsibilities Assist … wide range of molecular biology reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers’ technical support activities. Hands-on More ❯

Comfortable working in a small, fast-paced, and collaborative environment. Proficiency in project management tools (e.g., MS Project, Jira, Confluence, or equivalent). Familiarity with regulated environments (such as ISO 13485) is a plus. Desirable Experience in optical systems, ophthalmic devices, or AR/VR hardware. Project management certification (e.g., PMP, Prince2, Agile/Scrum). Experience balancing More ❯

SCRUM is essential. If you're confident facilitating, coaching, and communicating across teams, you'll fit right in. You'll also need to be familiar with regulatory standards like ISO 13485, IEC 62304, and FDA's 21 CFR Part 820. Experience working on products that combine hardware and software is important, especially if you've delivered medical device More ❯

cryptographically protected communication channels Knowledge about implementation of BLE systems for secure and robust communications Experience developing embedded systems for early-stage medical devices under IEC 60601, 62304, and ISO 13485 Notice By submitting your application, you acknowledge that Motif Neurotech will process your personal data for recruitment purposes. This includes evaluating your qualifications, contacting you regarding the More ❯

SQL Experience working with data lakes, warehouses, and large-scale datasets Understanding of data privacy and security principles Exposure to life sciences, genomics, or regulated medical environments (such as ISO 13485) or significant work within this sector/environment Comfortable working across both on-premise and cloud-based data systems Clear communicator, able to translate complex data concepts More ❯