Outside IR35, Uk wide, Quality Management, London, QMS, ISO13485, Immediate Start, Agile, ISO 14971, AI, My leading client is looking for a strategic QMS Lead to build and embed an ISO13485 -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 ISO13485 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 ISO13485 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, ISO13485, 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 ISO13485-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 ISO13485 , 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 ISO13485 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 ISO13485 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 ❯
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 ISO13485 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 ❯
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 ISO13485 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 ISO13485 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 ❯
