20 of 20 DemandTrendPermanent ISO 13485 Jobs in England

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 ❯

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 ❯

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 ❯

High volume Contract Manufacturers and ATE requirements Familiarity with CI/CD pipelines and automated testing Experience in embedded cybersecurity Experience working under a Quality Management System e.g. ISO9001, ISO13485 Education and Qualification Relevant Degree in Software or Electrical Engineering preferred Interested Candidates without a formal Degree but significant relevant experience should still apply. 5+ years in Embedded Hardware Design 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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

Out: ? Real ownership of Quality & HSE systems ? Influence group-wide safety and compliance initiatives ? Collaborative, high-performing team ? Exceptional benefits and career development ?? Key Responsibilities: Accreditation & Compliance Maintain ISO9001, ISO13485, ISO18001, ISO14001, and ISO45001 standards Conduct internal and external audits Ensure REACH and ROHS compliance Manage CAPA and document control systems Quality Control Improve manufacturing quality controls to reduce defects … Were looking for someone with: Proven track record in a quality management role within electronics manufacturing or a similarly regulated industry Strong working knowledge of ISO standards (ISO9001, ISO13485, ISO14001, ISO45001) Proven experience in QMS development , Lean , and Continuous Improvement (CI) methodologies Familiarity with embedded systems , cables , touch screens , or electronic engineering Experience managing supplier quality , customer returns , and More ❯

Lakes and Data Warehouses; create robust data transformation processes that ensure data quality, consistency and security and implement automation workflows. You will help to maintain compliance with ISO27001 and ISO13485 requirements for healthcare data management and ensure that security first practices are employed in all data processing solutions to protect sensitive patient information. This is a great opportunity to join … working with sensitive patient data You have a strong understanding of healthcare data standards (HL7, FHIR, OMOP, SNOMED) and data modelling; as well as healthcare technology and regulatory requirements (ISO13485, ISO27001) You have experience of managing data in Azure using tools such as Azure Data Factory, Azure Databricks, Azure Synapse Analytics You have a good knowledge of Data Lake and More ❯