18 of 18 ISO 13485 Jobs in the UK

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 ❯

with the quality/regulatory team to ensure customer complaints, feedback, incidents and notifiable events are handled in accordance with the company's procedures for post-market surveillance (under ISO 13485 and EU MDR). Work closely with the software, firmware, hardware, operations and quality teams to resolve technical issues promptly and to ensure a positive customer experience … or other relevant data-oriented discipline (or equivalent industrial experience) Experience working with medical devices that include a software or firmware component Experience working within a quality management system (ISO 13485 or ISO 9001), or in a regulated industry Industrial experience as Tier 2 or 3 Technical Support Engineer or similar role Experience in an early-stage More ❯

medical technologies. Key Responsibilities Define, manage, and document system requirements, including leading user workshops. Develop system architectures and evaluate alternative technologies. Ensure compliance with medical device standards such as ISO 14971, IEC 60601, and ISO 13485 . Lead governance activities, including Critical Design Reviews (CDRs). Support Verification, Validation, and system qualification processes. Conduct detailed risk management … critical environment. Strong knowledge of systems engineering disciplines (requirements, architecture, V&V, release). Expertise in software, mechanics, electronics, or physics , with broad technical awareness across disciplines. Experience applying ISO 14971 risk management and IEC 60601 safety standards. Proficiency in systems engineering tools and methodologies (MBSE, SysML, UML). Strong analytical, problem-solving, and communication skills. Desirable: Experience in … R&D within a medical device environment (ISO 13485 compliance). Knowledge of real-time control systems, PLCs, and networked system security. Strong commercial and business awareness. Excellent team player with a passion for advancing medical technologies. If you are interested in the role of Principle Systems Engineer and feel that you have the relevant experience, please contact 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 ❯

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 ❯

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. Strong knowledge of IEC 60601-1 standards for safety and performance in medical systems. Background in systems engineering disciplines: requirements management, architecture … V&V, and release. Proficiency in requirements engineering and risk analysis techniques across the device lifecycle. Strong understanding of ISO/IEC/IEEE 15288 systems engineering lifecycle within regulated environments. 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 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 ❯

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 ❯

the product from design to manufacturing, solving engineering issues in electronics, firmware, and production instrumentation Maintain, adapt, and optimise existing firmware within the constraints of regulatory compliance (IEC 62304, ISO 13485) Lead electronics design, schematic capture, and PCB layout using Altium Develop LabVIEW applications for test and instrumentation Collaborate with manufacturing partners to troubleshoot and resolve production issues More ❯

ll need to apply: 4+ years in a data engineering or similar role, building and maintaining data pipelines Exposure to life sciences, genomics, or regulated medical environments (such as ISO 13485) or significant work within this sector/environment Exposure to genomic data formats and tools Exposure to GCP Strong experience with Python and SQL Experience working with More ❯

youll need to apply: 4+ years in a data engineering or similar role, building and maintaining data pipelines Exposure to life sciences, genomics, or regulated medical environments (such as ISO 13485) or significant work within this sector/environment Exposure to genomic data formats and tools Exposure to GCP Strong experience with Python and SQL Experience working with More ❯

documentation. Strong understanding of automation principles, control systems, robotics, and data management. Strong understanding of automation principles, control systems, robotics, and data management. Familiarity with quality management systems (e.g., ISO 13485) and regulatory requirements for medical devices. Effective communication and collaboration skills to work with diverse team. What do we offer? Competitive salary and benefits! With us, you 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 ❯

excellent benefits. Location: Cardiff Software Design Manager Responsibilities: Carry out engineering activities in accordance with company QA procedures and to meet regulatory regimes such as Medical Device Regulation (EU), ISO13485 (Int), FDA CFR820 (USA) and appropriate standards including IEC 60601, IEC 62304, ISO 14971. Management of resources providing motivation, supervision and guidance of software engineering staff. Ensure adherence to More ❯

excellent benefits. Location: Cardiff Software Design Manager Responsibilities: Carry out engineering activities in accordance with company QA procedures and to meet regulatory regimes such as Medical Device Regulation (EU), ISO13485 (Int), FDA CFR820 (USA) and appropriate standards including IEC 60601, IEC 62304, ISO 14971. Management of resources providing motivation, supervision and guidance of software engineering staff. Ensure adherence to More ❯

company's solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001. Who we're looking for Dot Compliance is a leading provider of cloud Quality and Compliance management solutions for the life science industry. More ❯