1 to 25 of 38 ISO 13485 Jobs in England

you must be able to attend the Trust Hospital site in person** Main duties of the job The Quality & Information System Manager is responsible for the Clinical Engineering Department ISO registration and ongoing compliance as well as the databases used within Clinical Engineering. Responsible also for co-ordinating the training programmes for ISO and databases for all clinical … on one of the Trust sites Mon-Fri, with the occasional service need to work out of hours.o To maintain comprehensive training records for clinical engineering personnel relating to ISO and the databases.o To organise and co-ordinate internal/external training programmes for clinical engineering personnel.o To assist the senior management team in maintaining the departments database and … ISO 13485 Quality Management System (QMS) ensuring all associated paperwork is maintained and current.o Main site of work is at University Hospital Lewisham, but the post holder may also be required to start work on any site used by the Trust. Travel between sites may be required within a working day, for example to travel between University Hospital More ❯

and strategically minded RA/QA Senior Specialist with deep expertise in Software as a Medical Device (SaMD) and artificial intelligence (AI) regulatory frameworks, including the EU AI Act, ISO/IEC DIS 42001 (AI Management System), ISO/IEC 23894 (AI Risk Management), BS 30440:2023 (Validation framework for AI in healthcare), and MHRA guidance on Software … environment, ensuring alignment with evolving global standards and supporting innovation in regulated software development. Provide strategic oversight for interpreting and implementing regulatory frameworks such as the EU AI Act, ISO/IEC DIS 42001, ISO/IEC 23894, BS 30440:2023, ensuring comprehensive alignment with ethical, technical, and compliance considerations specific to AI and LLM applications in SaMD. … translating complex regulations into clear, strategic actions for cross-functional teams. Software Development Lifecycle: Provide strategic leadership over the software development and release management process, ensuring comprehensive compliance with ISO 62304 and ISO 13485. Collaborate closely with engineering leadership to ensure that software modifications and updates adhere rigorously to regulatory and quality expectations before approval and deployment. Lead More ❯

s revolutionising medical diagnostics and transforming patient care. Key Responsibilities Oversee and develop our medical device Quality Management System (QMS) and Information Security Management System (ISMS), ensuring compliance with ISO 13485, MDSAP, US FDA QSR, EU MDR and ISO 27001. Implement and secure certification for an Artificial Intelligence Management System in line with ISO 42001 and … or related field. Minimum 5 years of hands-on QMS management experience in medical devices, preferably with AI/Software as a Medical Device (SaMD) products. Demonstrable expertise in ISO 13485, EU MDR and FDA QSR (21 CFR 820) quality system requirements. Proven track record supporting external audits (notified body, FDA inspections). Experience leading significant management system … changes and improvements. Strong analytical and problem-solving skills, with ability to find pragmatic and creative solutions. Certification as a Lead Auditor (ISO 13485) and/or Certified Quality Auditor (CQA) is a plus. Competitive salary Share options package - all our employees have ownership in the company Private healthcare 25 days annual leave (+ company shut down in More ❯

a Quality Assurance Specialist to join a leading pharmaceutica logistics company. This role focuses on supporting the implementation and maintenance of the Quality Management System (QMS) in line with ISO 9001 and ISO 13485 standards, and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements. … Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong knowledge of GDP, GMP, ISO 9001, and ISO 13485 standards. Excellent organizational, communication, and stakeholder management skills. More ❯

a Quality Assurance Specialist to join a leading pharmaceutica logistics company. This role focuses on supporting the implementation and maintenance of the Quality Management System (QMS) in line with ISO 9001 and ISO 13485 standards, and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements. … Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong knowledge of GDP, GMP, ISO 9001, and ISO 13485 standards. Excellent organizational, communication, and stakeholder management skills. 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 ❯

UK. Job description Job responsibilities DUTIES AND RESPONSIBILITIES General Ensure all work complies with current UK legislation for work with ionising radiation (IRR 2017, IRMER 2017) and the Trusts ISO 9K2K-compliant quality management system for provision of radiotherapy. The post holder will be expected to prioritise and manage their own work on a day-to-day basis. The … Knowledge Essential oKnowledge of radiotherapy physics oUnderstanding of the role of computational systems in radiotherapy oKnowledge of relevant legislation, national standards, and professional guidelines (e.g. IRR'99, IRMER 2000, ISO:9K2K, ISO 13485, ISO 14971, IPEM Codes of Practice, GDPR, Data Protection Act) Desirable oTheoretical Machine Learning/AI and statistics knowledge oUnderstanding of principles of More ❯

and product validation, iterating based on test results and feedback. Collaborate with suppliers on design reviews, ensuring cost-effective, reliable manufacturing. Ensure compliance with relevant regulatory and quality standards (ISO 9001, CE, RoHS, EMC considerations). Support root cause analysis and continuous improvement (CI) activities during and post NPI. Document processes and design changes, maintaining alignment with engineering change … understanding of DFM/DFA principles. Ability to work closely with cross-functional teams (electronics, firmware, quality, production). Experience in risk assessment, FMEA, and quality documentation aligned with ISO 9001 or similar. Comfort with prototyping, debugging, and iterative design. Nice to Have Experience in RFID/NFC, barcode scanners, or imaging devices mechanical design. Familiarity with ISO 13485, ISO 14971, or similar regulated environments. Exposure to Lean Manufacturing, Six Sigma methodologies. Experience designing test fixtures for production and QA. Familiarity with IP rating considerations for rugged devices. Why us? Work on real hardware products that ship globally. See your designs in use in airports, banks, and secure environments worldwide. Join a collaborative, engineering-led More ❯

Electronic Medical Records (EMR)solution called Clinicalvision, designed specifically for the renal market and the management of clinical records for CKD, ESRD and transplant patients. Clinical Computing is an ISO 13485 Medical Device certified organisation. Clinical Computing along with Mediqal H.I., its sister company in the UK, are both members of the Constellation Kidney Group. Key Responsibilities Create … also be familiar with help desk software. Ultimately, you will help maintain our reputation as a company that offers excellent customer support. Responsibilities Undertake activities in accordance with our ISO 13485 Medical Device Quality Management System. Diagnose and troubleshoot technical issues. Ask customers targeted questions to quickly understand the root of the problem. Track computer system issues through More ❯

procedures, identify instrument/component performance, ensuring all observations and data are recorded. Analysing results and experimental data to determine pass/fail. All activity to comply to ISO9001 & ISO 13485 (cGMP) Responsible to the Maldi Test Manager for: Final test of MALDI TOF instrument systems, checking their performance for reliability and specification levels under a various conditions. … team measures, facilitating and driving continuous improvements. When required, train new engineers and peers. Correct use of tools and processes, described in SAMI's & Test procedures. Comply to ISO9001 & ISO 13485 (cGMP) If required Commissioning of instruments within the U.K. and R.O.W. territories Qualifications (E/D): Degree/HND science/engineering basis; Chemistry, Physics, Biological, Electronics 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 ❯

through certification under UK MDR You're highly self-starting, proactive, and comfortable working autonomously You have deep knowledge of UK MDR and strong working familiarity with IEC 62304, ISO 14971, and ISO 13485 You've worked in fast-moving digital health teams and can balance regulatory compliance with the realities of iterative product development You're More ❯

trend analysis, clinical evaluation reports including literature search, post market clinical follow-up studies, and vigilance reporting. Regulatory & Medical Device Compliance Support compliance with UK MDR, EU MDR, and ISO standards (e.g., ISO 13485). Contribute to the preparation of regulatory submissions and audits by providing clinical evidence and safety documentation. Participate in internal and external audits More ❯

to continual process improvement across the business. Responsibilities as a Quality Systems Engineer in Andover. Develop and maintain the Business Management System and supporting software platform. Ensure compliance with ISO 9001, AS 9100, ISO 13485, and related standards. Conduct investigations using 8D, Ishikawa, and 5WHY methodologies. Lead or support internal audits and prepare for certification, regulatory, and … system performance. Requirements as a Quality Systems Engineer in Andover. 3+ years of experience in quality management within manufacturing or product development. Strong working knowledge of ISO9001, AS 9100, ISO13485, and ISO14001. Degree in Electrical or Mechanical Engineering (or equivalent experience). If you are interested in this Quality Systems Engineer job in Andover. then APPLY NOW. 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 ❯

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 ❯

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 ❯

on integration needs. Familiarity with integrating automated liquid handling solutions Participation in product development and experience with verification and validation activities for automation workflows; familiarity with regulated environments (e.g., ISO 13485, IVD, CLIA) is helpful but not required. Strong collaboration and communication skills, with the ability to work in fast-paced, cross-functional environments. Comfortable reprioritizing project work 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 ❯

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 ❯

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 ❯

team of engineers across multiple disciplines (mechanical, electrical, software, systems) Oversee the design, development, testing, and validation of innovative medical devices in accordance with regulatory standards (e.g. FDA, CE, ISO 13485) Drive project execution, ensuring timely delivery, budget adherence, and product quality. Collaborate cross-functionally with R&D, Quality, Regulatory, and Project teams to align engineering efforts with More ❯