1 to 25 of 85 ISO 13485 Jobs in the UK

support the Head of QA, responsible person and responsible personfor import, in the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and ISO 13485 standards, and in compliance with EU GDP guidelines. Ideally you will have experience of working in a GMDP … Persons and Qualified Persons with the implementation and maintenance of the Quality Management System in accordance with the GMP and GDP guidelines and GPhC, ISO 9001 and ISO 13485 standards. Supporting the ongoing compliance with relevant standards, legal requirements, regulations and the PSDL documented policies and procedures. ...

within the medical device or regulated environment. Demonstrated success in software validation and verification, ideally with exposure to medical device standards (e.g., IEC 62304, ISO 13485). Strong organizational and project management skills. Key Competencies Expertise in developing and implementing robotic manipulation algorithms (e.g., motion planning, control, perception … C++, Python, or related languages for robotic software development. Strong grasp of software validation methodologies, automated testing, and quality assurance processes. Knowledge of ISO 13485, MDD/IVDD, IEC 60601x, ISO 14971, and risk management documentation is a plus. Communication Excellent communication skills are essential ...

technical strategy. Develop novel approaches to overcome product development challenges. Maintain quality records across chemistry, consumables, and instrument activities. Ensure documentation complies with ISO 13485 requirements in collaboration with Quality. About You You ll bring a strong background in systems engineering within IVD, diagnostics or closely regulated medical … Excellent communication, documentation, and cross-functional collaboration skills. Strong root-cause analysis skills across electro-mechanical and instrument systems. Experience applying standards such as ISO 13485, IEC 62304, 21 CFR 820, IVDR, IEC 62366. Familiarity with ISO 14971 risk management (FMEA, FTA etc.). Broad engineering understanding ...

verification. Champion software engineering best practices version control, code reviews, CI, and automation. Support risk management, audits, and continuous improvement in line with ISO 14971 and ISO 13485. Mentor junior engineers and promote high technical and quality standards. Deliver assigned work packages to meet technical, schedule, and quality … medical software. Familiarity with cloud computing or containerisation (Docker, AWS, Azure) for test and data systems. Strong working knowledge of IEC 62304 (software lifecycle), ISO 13485 (QMS), and ISO 14971 (risk management). Experience working with Notified Bodies, FDA, or MHRA on software-related submissions. Strong mentorship ...

UART, ADC, PWM) • IoT protocols (Wi-Fi, BLE, MQTT) • Confident with lab tools: oscilloscopes, spectrum analysers, soldering fine-pitch components • Experience working within ISO 13485 or ISO 9001 quality systems Email a CV to danni@cortechtalentsolutions.co.uk ...

teams to support defect triage, issue resolution, and validation. Monitor regulatory changes and ensure compliance with standards such as IEC 60601 and ISO 14971. Conduct risk management activities including FMEA and hazard analysis. Champion continuous improvement across engineering tools and processes. Required Experience & Qualifications Essential: Bachelors degree in biomedical … mechanical, electrical, or systems engineering (or equivalent). Strong background in high-reliability systems (e.g., ventilators). Deep understanding of ISO 14971 and IEC 60601-1 standards. Proven experience in systems engineering disciplines: requirements, architecture, design, V&V, and release. Familiarity with ISO/IEC/IEEE ...

Head Office in Basingstoke. What will you be doing? As Quality Assurance Engineer , you will provide Quality Assurance support to our Quality Management System (ISO13485:2016) whilst assisting meeting our Regulatory responsibilities. This role is offered on a hybrid basis, with the expectation of 3-4 days onsite per week. … duties: Supporting the Implementation, maintenance, continuous improvement, and support of Blatchford's Quality Management Systems (in line with ISO13485:2016) and the Medical Device Regulations). Collaborating across internal departments to provide Quality Assurance support. Participating in external Quality aud it activities . R epresenting QA for various projects across ...

Experience working with real-time or resource-constrained systems - Understanding of microcontrollers and hardware interfaces - An appreciation of medical device development standards such as ISO 13485, IEC 62304 or similar (desirable) - A methodical approach to testing, documentation and quality - Strong communication and teamwork skills Why Apply? This ...

Experience working with real-time or resource-constrained systems - Understanding of microcontrollers and hardware interfaces - An appreciation of medical device development standards such as ISO 13485, IEC 62304 or similar (desirable) - A methodical approach to testing, documentation and quality - Strong communication and teamwork skills Why Apply? This ...

Experience working with real-time or resource-constrained systems - Understanding of microcontrollers and hardware interfaces - An appreciation of medical device development standards such as ISO 13485, IEC 62304 or similar (desirable) - A methodical approach to testing, documentation and quality - Strong communication and teamwork skills Why Apply? This ...

collaboration. Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders. Create and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP. Assist in the preparation and submittal of registration applications. May assist in the preparation ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

projects end-to-end. Understanding of healthcare software systems or medical devices, ideally within surgical or interventional settings. Working knowledge of regulatory frameworks (e.g. ISO 13485). Strong communication and collaboration skills - confident engaging with engineers, clinicians, and stakeholders. Excellent attention to detail and organisational ability. Flexible, proactive ...

integrated product design and engineering consultancy. Specialising in electronics, software and mechanical engineering, industrial design, human factors and project management. eg is ISO 13485 accredited, complying with safety, risk management and traceability standards. Our engineers are world-class and have the experience and passion to create exceptional products ...

integrated product design and engineering consultancy. Specialising in electronics, software and mechanical engineering, industrial design, human factors and project management. eg is ISO 13485 accredited, complying with safety, risk management and traceability standards. Our engineers are world-class and have the experience and passion to create exceptional products ...

integrated product design and engineering consultancy. Specialising in electronics, software and mechanical engineering, industrial design, human factors and project management. eg is ISO 13485 accredited, complying with safety, risk management and traceability standards. Our engineers are world-class and have the experience and passion to create exceptional products ...

integrated product design and engineering consultancy. Specialising in electronics, software and mechanical engineering, industrial design, human factors and project management. eg is ISO 13485 accredited, complying with safety, risk management and traceability standards. Our engineers are world-class and have the experience and passion to create exceptional products ...

integrated product design and engineering consultancy. Specialising in electronics, software and mechanical engineering, industrial design, human factors and project management. eg is ISO 13485 accredited, complying with safety, risk management and traceability standards. Our engineers are world-class and have the experience and passion to create exceptional products ...

integrated product design and engineering consultancy. Specialising in electronics, software and mechanical engineering, industrial design, human factors and project management. eg is ISO 13485 accredited, complying with safety, risk management and traceability standards. Our engineers are world-class and have the experience and passion to create exceptional products ...

integrated product design and engineering consultancy. Specialising in electronics, software and mechanical engineering, industrial design, human factors and project management. eg is ISO 13485 accredited, complying with safety, risk management and traceability standards. Our engineers are world-class and have the experience and passion to create exceptional products ...

integrated product design and engineering consultancy. Specialising in electronics, software and mechanical engineering, industrial design, human factors and project management. eg is ISO 13485 accredited, complying with safety, risk management and traceability standards. Our engineers are world-class and have the experience and passion to create exceptional products ...

integrated product design and engineering consultancy. Specialising in electronics, software and mechanical engineering, industrial design, human factors and project management. eg is ISO 13485 accredited, complying with safety, risk management and traceability standards. Our engineers are world-class and have the experience and passion to create exceptional products ...

integrated product design and engineering consultancy. Specialising in electronics, software and mechanical engineering, industrial design, human factors and project management. eg is ISO 13485 accredited, complying with safety, risk management and traceability standards. Our engineers are world-class and have the experience and passion to create exceptional products ...