22 of 22 ISO 13485 Jobs in England

Outside IR35, Uk wide, Quality Management, London, QMS, ISO 13485, Immediate Start, Agile, ISO 14971, AI, My leading client is looking for a strategic QMS Lead to build and embed an ISO 13485 -aligned Quality Management System for a cutting-edge healthcare platform. You'll drive compliance, shape governance, and prepare the business for audits … and accreditation-all while working closely with agile product teams. What You'll Do: Own the QMS strategy for SaMD. Lead ISO 13485 gap analysis and rollout. Embed QMS into agile workflows across product squads. Deliver training and drive adoption across tech teams. Liaise with auditors and regulators. Champion continuous improvement and quality culture. What You'll Bring … Deep ISO 13485 expertise in healthcare software. Proven track record from QMS design to accreditation. Strong grasp of Agile/DevOps in regulated environments. Confident communicator with top-tier documentation skills. Experience in pharma or MedTech platforms. Familiarity with ISO 14971, IEC 62304. Exposure to AI-enabled QMS tooling. If this role is of interest please send More ❯

QMS, SaMD, ISO 13485, IEC 62304, ISO14971, Medtech, Digital Healthcare, Software Development Lifecycle, Agile, Dev Ops My consultancy client is looking for a QMS lead with deep SaMD expertise to shape the future of digital healthcare services. You will lead the design, implementation, and continuous improvement of our ISO 13485-aligned QMS for our a cutting … as Software as a Medical Device (SaMD) . The key areas of expertise are to Own the QMS vision and strategy for the SaMD programme. Ensure full alignment with ISO 13485 , IEC 62304 , and ISO 14971 standards. Embed QMS principles into agile product squads without compromising delivery velocity - Strong understanding of software development life cycles (Agile, DevOps … in regulated environments. Prepare the organisation for external audits and ISO accreditation . Champion a culture of continuous improvement and quality-first thinking If this sounds of interest please send me your cv ASAP for review 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 ❯

contribute to the success of a leading medical device company, we want to hear from you! Key Responsibilities: Assist in maintaining compliance with certifications and regulatory approvals such as ISO 27001, ISO 9001, ISO 13485, UKCA, CE, and FDA 510(k). Support the update and maintenance of QMS and ISMS documentation. Help coordinate and conduct … inclusive work environment. The Person Degree or equivalent qualification in Life Sciences, Quality Management, or a related field. 2+ years of relevant experience is preferred. A basic understanding of ISO standards or medical device regulations is desirable. Excellent organisational skills with strong attention to detail. Clear written and verbal communication abilities. A commitment to following procedures and maintaining accurate More ❯

scale) sourced from external manufacturers. Hands-on bring-up testing of assembled boards. Manufacture of wiring harnesses and integration of PCBs into hardware products. Identifying, evaluating, and testing external ISO 13485 accredited electronics assemblers and suppliers. Feeding back into the design process to improve manufacturability and performance. Working closely alongside other engineers in the team. Must-haves: Strong … with electronic circuit design. Familiarity with PCB design tools (KiCAD, EAGLE, Altium). Experience debugging circuits and interpreting assembly instructions. Layout experience on stripboard/matrix board. Awareness of ISO 13485 quality standards. Confident communicator who can explain technical concepts clearly. Why Apply? This is more than just an electronics assembly technician role - it's a chance to More ❯

scale) sourced from external manufacturers. Hands-on bring-up testing of assembled boards. Manufacture of wiring harnesses and integration of PCBs into hardware products. Identifying, evaluating, and testing external ISO 13485 accredited electronics assemblers and suppliers. Feeding back into the design process to improve manufacturability and performance. Working closely alongside other engineers in the team. Must-haves: Strong … with electronic circuit design. Familiarity with PCB design tools (KiCAD, EAGLE, Altium). Experience debugging circuits and interpreting assembly instructions. Layout experience on stripboard/matrix board. Awareness of ISO 13485 quality standards. Confident communicator who can explain technical concepts clearly. Why Apply? This is more than just an electronics assembly technician role - it's a chance to More ❯

a small company environment Strongly Advantageous: Experience in optoelectronics, PID temperature control, and reliability testing Expertise in IVD/medical device compliance (EU & USA) Experience in regulated product development (ISO 13485, IVDR, 60601, EMC standards, FDA approvals) If you're ready to make a real impact, apply today! How to apply for the role: If you have the 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 ❯

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 ❯

engineering governance activities, including Critical Design Reviews (CDRs). Collaborate with verification and validation teams to support defect triage and resolution. Monitor regulatory standards, ensuring compliance with IEC 60601, ISO 14971, and other relevant frameworks. Conduct risk management activities, including FMEA, hazard analysis, and early-phase risk reviews. Provide technical input, risk assessments, and continuous improvement recommendations during project … s degree (or equivalent) in Biomedical, Mechanical, Electrical, Systems Engineering, or related discipline. Proven problem-solving skills in high-reliability, life-supporting systems (e.g., ventilators). Demonstrated experience applying ISO 14971 risk management to medical device development as well as IEC 62304 Background in systems engineering disciplines: requirements management, architecture, V&V, and release. Proficiency in requirements engineering and … risk analysis techniques across the device lifecycle. Experience working cross-functionally in multidisciplinary teams. Desirable Skills Experience in R&D within regulated industries, ideally under ISO 13485 and IEC 60601. Knowledge of real-time control systems, control theory, and embedded platforms. Strong collaboration and communication skills, with enthusiasm for advancing medical technologies. If you are interested in the More ❯

manufacturing). Proficiency with project management frameworks (Agile, Waterfall) and tools (e.g., MS Project, Jira, Confluence). Excellent client-facing and stakeholder management skills. Familiarity with regulated environments (e.g., ISO 13485, medical device directives) is highly desirable, though not essential. Project management certification (PMP, PRINCE2, Agile/Scrum) would be advantageous. Why Join? This is a career-defining More ❯

manufacturing). Proficiency with project management frameworks (Agile, Waterfall) and tools (e.g., MS Project, Jira, Confluence). Excellent client-facing and stakeholder management skills. Familiarity with regulated environments (e.g., ISO 13485, medical device directives) is highly desirable, though not essential. Project management certification (PMP, PRINCE2, Agile/Scrum) would be advantageous. Why Join? This is a career-defining 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 ❯

a mechanical/electrical mindset. Excellent communication and customer service skills. A proactive, independent worker who's flexible and travel-ready. Full UK driving licence (essential). Knowledge of ISO 13485/CE/UKCA quality standards is desirable but not essential. What's on Offer Competitive salary based on your skills and experience. Performance-based bonus scheme. More ❯

a mechanical/electrical mindset. Excellent communication and customer service skills. A proactive, independent worker who's flexible and travel-ready. Full UK driving licence (essential). Knowledge of ISO 13485/CE/UKCA quality standards is desirable but not essential. What's on Offer Competitive salary based on your skills and experience. Performance-based bonus scheme. More ❯

a mechanical/electrical mindset. Excellent communication and customer service skills. A proactive, independent worker who's flexible and travel-ready. Full UK driving licence (essential). Knowledge of ISO 13485/CE/UKCA quality standards is desirable but not essential. What's on Offer Competitive salary based on your skills and experience. Performance-based bonus scheme. More ❯

EKS). An understanding of Linux system administration and networking concepts would be useful Any experience of working within a regulated setting and working to one or more of: ISO 13485, 27001, 9001 would be advantageous The list above is important, but not as important as hiring the right person! So if you don't meet all of More ❯

Some experience with containerisation and orchestration (Docker, ECS, or EKS) An understanding of Linux system administration (Ubuntu, Amazon Linux, etc.) Any experience of working within one or more of: ISO 13485, 27001, 9001 would be advantageous The list above is important, but not as important as hiring the right person! So if you don't meet all of More ❯

be working across engineering and R&D teams to support the design, integration, and commercialisation of semiconductor-based and biocomputing technologies. Your role will span product architecture, documentation to ISO 13485 standards, and hands-on delivery of systems that combine hardware, software, and biology. You'll collaborate with internal stakeholders and external partners to align technical execution with More ❯

improvement in patient outcomes. Your new role As QA Compliance Manager, you'll lead a team responsible for maintaining and improving the Quality Management System in line with GMP, ISO, and regulatory standards. Reporting to the Head of Quality, you'll oversee internal audits, batch record reviews, CAPA systems, and customer audits. You'll also contribute to strategic quality … discipline (e.g. Chemistry, Biology, or related field) Extensive experience in GMP-regulated environments (10+ years preferred) Strong leadership and people management skills In-depth knowledge of EU cGMP and ISO standards (9001, 13485) Experience supporting or conducting batch release under QP supervision Lead auditor training and a proactive approach to continuous improvement Excellent communication, organisational, and stakeholder engagement More ❯

supporting clinical trials and ensuring compliance with international standards. Key Responsibilities Define and document system architecture, design inputs, and interfaces. Lead risk management activities (FMEA, FTA) in compliance with ISO 14971. Maintain technical documentation (DHF) for audits and regulatory submissions. Manage system and sub-system requirements with full traceability. Support clinical investigations and verification testing. Collaborate with cross-functional … and regulatory. Drive process improvements and stay current with evolving standards. Skills & Experience Essential: Degree in engineering or a related field. Experience in regulated medical device development. Familiarity with ISO 14971 & ISO 13485. Strong understanding of system-level requirements and V&V principles. Desirable: Experience with implantable or active medical devices. Knowledge of IEC 60601, IEC 62304, or … ISO 14708. Proficiency with document control and requirements management tools. Experience working with clinical and academic partners. Whats on Offer Competitive salary based on experience. Private healthcare, income protection, life assurance. Company pension scheme. 27 days holiday plus bank holidays. Hybrid working. The opportunity to contribute to a transformative medical technology platform. More ❯