22 of 22 Permanent ISO 13485 Jobs in the UK

scale effectively. You will take full ownership of the Quality Management System (QMS), oversee medical device compliance, and act as the internal lead for ISO standards. This role combines strategic oversight with hands-on execution and will be critical in building scalable, audit-ready processes. There is also … product develops (features, integrations, deployments) Work closely with product and engineering teams to embed compliance into development processes Act as the internal lead for ISO standards (including ISO 13485 and ISO 27001) Maintain audit readiness across documentation, policies, and controls Lead preparation for audits, inspections ...

scale effectively. You will take full ownership of the Quality Management System (QMS), oversee medical device compliance, and act as the internal lead for ISO standards. This role combines strategic oversight with hands-on execution and will be critical in building scalable, audit-ready processes. There is also … product develops (features, integrations, deployments) Work closely with product and engineering teams to embed compliance into development processes Act as the internal lead for ISO standards (including ISO 13485 and ISO 27001) Maintain audit readiness across documentation, policies, and controls Lead preparation for audits, inspections ...

using cutting-edge additive manufacturing. This is a hands-on Quality Engineer role where youll play a key part in maintaining and improving an ISO 13485 QMS while supporting product development, validation, and regulatory activities ahead of major commercial launches. What youll be doing: Own and maintain … ISO 13485) Manage document control, CAPAs, and change control Support NPD, validation, and testing activities Conduct internal audits and support external/regulatory audits Work closely with engineering and clinical teams What were looking for: 2+ years in medical device quality Strong knowledge of ISO 13485 ...

security activities including Product Defense in Depth, security technology, regulatory compliance and incident response Domain specific standards and approaches on privacy and product security (ISO 2700x, NIST 800 Series Special Publications) Knowledgeable and experience with laws and regulations on cyber security, privacy, data protection and breach notification (e.g. … cyber security guidelines, 95/46/ED, HIPAA, GDPR, ISO 13485, ISO 14971. ISO 27001/27017/27018, ISO 30111; AAMI TIR 57; 21CFR820, SB1386, etc.) Experience in designing or leading software products using Secure SDLC Thorough Understanding of securing and hardening Windows ...

security activities including Product Defense in Depth, security technology, regulatory compliance and incident response Domain specific standards and approaches on privacy and product security (ISO 2700x, NIST 800 Series Special Publications) Knowledgeable and experience with laws and regulations on cyber security, privacy, data protection and breach notification (e.g. … cyber security guidelines, 95/46/ED, HIPAA, GDPR, ISO 13485, ISO 14971. ISO 27001/27017/27018, ISO 30111; AAMI TIR 57; 21CFR820, SB1386, etc.) Experience in designing or leading software products using Secure SDLC Thorough Understanding of securing and hardening Windows ...

help shape quality excellence at Guilford Street Laboratories. Key Responsibilities: Support the maintenance and continuous improvement of the IMS Assist with compliance across ISO 15189, ISO 13485, ISO 27001, UKCA, CE, and relevant FDA/IVDR requirements Manage controlled documentation, including SOPs, policies, and laboratory procedures ...

middleware. Writing code and algorithms in accordance with good Software practise - Experience of relevant standards and medical device regulations would be beneficial (e.g. ISO 13485, ISO 9001 ISO 14971 and IEC 62304.) Development of test plans and procedures, conducting and accurately documenting the tests at unit … external stakeholders e.g. production, service, sales teams and suppliers. Knowledge, Skills & Experience: Have experience of software development for medical devices or similar within an ISO regulated environment and be able to work to associated regulations such as IEC 62304. Be able to work efficiently with source code management tools. ...

sector . The Quality Assurance (QA) Assistant is responsible for developing, maintaining, and continuously improving the companys Quality Management System (QMS) in line with ISO 9001, customer, and regulatory requirements. This role focuses on system compliance, process improvement, supplier quality management, audit preparation and participation, accurate ERP data management … supporting the achievement of strategic quality objectives. This includes: Supporting the development, maintenance, and improvement of the companys Integrated Management System (IMS) to meet ISO 9001, ISO 14001, customer, and legal requirements. Assisting in planning, conducting, and following up on internal, supplier, and external audits. Monitoring supplier performance ...

independently Strong communication and collaboration skills, including distributed teams Desirable: Experience with Bluetooth/BLE integrations Medical device or regulated environment experience Experience with ISO 13485 or similar QMS Knowledge of IEC 62304, ISO 13485, or other relevant standards I f you’re passionate about building ...

/GCP) Proven track record managing product security in a regulated healthcare or medical device setting Regulatory landscape such as FDA guidance, HIPAA, GDPR, ISO 13485, ISO 14971, AAMI TIR 57, ISO 27001 series, and 21 CFR 820 among others Technical credibility across cloud architecture, network ...

quality standards and process improvements. Required Skills and Experience: Previous experience in a quality role within manufacturing or a regulated environment. Experience with ISO 9001 and ISO 13485 preferred. Strong organisational, problem-solving, and communication skills. Strong attention to detail and commitment to quality standards. Able ...

personable manner. Highly motivated and driven to improve and develop processes. Desirable Commercial or Academic experience in the neuroscience domain. Knowledge of GCP, ISO13485, ISO27001 and/or other similar quality systems. Understanding of Design Patterns. Understanding of Agile concepts. Knowledge of Git and DevOps. Knowledge of Docker and Kubernetes. ...

execute verification and validation strategies (including qualified tools and fixtures); and lead design transfer activities. Regulatory Compliance and QMS: Ensure supplier activities operate under ISO 13485 - compliant processes and deliver complete DHF/Technical Documentation regulatory expectations; align development to applicable standards. Risk, Submission and Audit Support: Lead … document risk management (ISO 14971), ensure readiness for UDI, labelling, post market surveillance, and change control, and support regulatory submissions and notified body audits by presenting clear technical rationales and objective evidence. Cross Functional and Stakeholder Integration: Integrate the electronics/software workstream with assay/chemistry, mechanical design ...

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 ...

regulatory standards. Develop detailed project plans, requirements, specifications, schedules, and risk analyses. Negotiate trade-offs between schedule, resources, and product features. Ensure adherence to ISO13485, FDA CFR 820:30, and IEC 62304 standards. Provide regular updates and formal reviews to senior management and stakeholders. Manage contract resources and ensure quality ...

Engineer - CMM Programmer , you will have the following: Key skills and experience: Degree or OMC/HNC equivalent Working knowledge of ISO9001, ISO13485 MS Office experience to a minimum of intermediate level Programming Video Measuring Machine (VMM) Good working knowledge of SolidWorks software Strong communicator with good interpersonal Analytical skills ...

Engineer - Medical Devices: - Design, develop, and maintain embedded software in C for medical devices and safety‐critical systems. - Produce high‐integrity code compliant with ISO 13485 and associated medical standards. - Lead on software architecture, design reviews, and technical decision‐making. - Collaborate closely with hardware, systems, and quality teams … engineering within the medical device sector. - Strong proficiency in Embedded C and bare metal programming. - Hands‐on experience developing safety‐critical code aligned with ISO 13485. - Familiarity with structured development methodologies (e.g., V‐model, IEC 62304‐aligned processes). - Strong debugging, problem‐solving, and documentation skills. Desirable/Advantageous ...

Devices: - Design, develop, and maintain embedded software in C/C++ for medical devices and safety‐critical systems. - Produce high‐integrity code compliant with ISO 13485 and associated medical standards. - Lead on software architecture, design reviews, and technical decision‐making. - Collaborate closely with hardware, systems, and quality teams … engineering within the medical device sector. - Strong proficiency in Embedded C and bare metal programming. - Hands‐on experience developing safety‐critical code aligned with ISO 13485. - Familiarity with structured development methodologies (e.g., V‐model, IEC 62304‐aligned processes). - Strong debugging, problem‐solving, and documentation skills. Desirable/Advantageous ...

products - Lead the full hardware development lifecycle including requirements, design, prototyping, testing, debugging and production support - Ensure compliance with regulatory standards (e.g., IEC 60601, ISO 13485) - Conduct EMC testing and troubleshoot hardware issues - Collaborate with cross-functional teams to deliver integrated solutions - Maintain accurate documentation and stay current ...

following would be a bonus: Skills in containerisation/orchestration (Docker, Kubernetes etc.); IaC; DynamoDB; Spring Boot and Gradle; knowledge of standards such as ISO 13485 or IEC 62304. This role is predominantly remote, with occasional attendance of the company's London office - you will therefore need ...

Strong understanding of software development lifecycle and version control (e.g., Git). Desirable experiences for an Embedded Software Engineer: + Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820 + 3+ years of experience in a regulated industry Apply today to join a highly innovative ...

embed a culture of quality across the business. QA Specialist key responsibilities: Own and maintain the document management system, ensuring all quality documents meet ISO 9001:2015 requirements. Design and deliver staff training on QMS processes, keeping training records accurate and up to date. Administer the Non-conformance … working closely with the H&S competent person and relevant duty owners. QA Specialist requirements: Hands-on experience working within a Quality Management System (ISO 9001:2015 and 13485:2016), ideally in the Life Sciences or Medical Devices sector. Practical involvement in internal and external audits. Confident with ...