20 of 20 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 ...

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 ...

management (FMEA, hazard analysis) and V&V. Key skills: + Strong knowledge of systems engineering lifecycle. + Skilled in risk management and regulatory compliance ISO 14971 + Experience of R&D in a regulated environment, ISO 13485 would be beneficial. The salary will ...

collaboration within a regulated medical software environment. What You'll Do Lead architecture and development of a high-performance iOS app. Work within ISO 13485/IEC 62304 processes and support product validation. Mentor developers and raise engineering standards. Collaborate with AI/ML, backend, product, and design ...

consider applicants from three backgrounds: Medical device specialists, experienced embedded software engineers with a background in medical, healthcare, or other regulated environments such as ISO 13485, IEC 62304, aerospace, automotive safety, and similar sectors Regulated industry engineers, with transferrable skills from other safety critical or regulated sectors ...

Senior role within a manufacturing or commercial environment across multiple sites. Experience of compliance regulations and how it relates to IT, such as ISO13485 and ISO9001 Experience of ISO27001 an advantage. Proven experience of managing a team. Experience of training users in new application use. Excellent skills in leadership, communication ...

assurance activities within our Healthcare division. You will work closely with the Validation Manager to ensure systems (including SAP) and quality processes meet GDP, ISO, FDA, and EU Annex 11 standards. Your Tasks Lead and support Computer System Validation (CSV) activities, including planning, executing, and documenting validation, re-validation … other enterprise systems, electronic QMS, and temperature monitoring systems. Strong documentation, analytical, and organisational skills. Knowledge of GAMP 5, validation principles, GDP, ISO 9001/13485, FDA 21 CFR Part 11, and EU Annex 11. Experience in healthcare, pharmaceutical, or medical device environments. Confident in audits, inspections ...

experience in supervising teams and delivering complex projects. Strong knowledge of software medical devices or safety-critical systems. Familiarity with ISO standards (ISO9001, ISO13485) and Systems Engineering V-Model. Skilled in systems thinking, engineering, or integration within MedTech or similar sectors. Qualifications Degree (or higher) in a Scientific/ ...