14 of 14 ISO 13485 Jobs in the UK

Channel Islands area The Successful Quality Assurance Manager Will Need: * Experience in a Quality Assurance role in commercial/Residential environments. * Strong knowledge of ISO 9001 and quality systems, with experience managing audits and compliance processes. *Demonstrable experience in inspections, audits, NCR management, and *Serious intent and ability … Quality Engineer, Site Quality Manager, Supplier Quality Manager, Quality Improvement Manager, Governance & Compliance Manager, Technical Compliance Manager, Compliance Manager, Audit Manager, Internal Audit Manager, ISO Manager, QHSE Manager, HSEQ Manager, SHEQ Manager, Quality & HSE Manager, Quality & Governance Lead, Risk & Compliance Manager, Quality Business Partner, Operational Excellence Manager, Continuous Improvement ...

Management Define, maintain, and communicate the product vision and roadmap aligned with company strategy. Gather and analyse user feedback, market trends, and regulatory requirements (ISO 13485, ISO 27001, ISO 42001, GDPR, AI Act). Translate compliance and business needs into clear functional requirements and prioritised backlogs. … focused on simplicity, automation, and regulatory alignment. Project & Delivery Leadership Lead product planning and release cycles within a defined QMS framework. Ensure compliance with ISO 27001 and support certification audits. Manage internal and external stakeholders including clients, partners, and leadership. Track milestones, identify risks, and ensure delivery on time ...

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 ...

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 … 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 (Essentials/Desirable): Degree/HND science/engineering ...

middleware, firmware and algorithm development. Writing well-documented, maintainable, and test-driven code in line with medical device & industry specific standards (e.g. IEC 62304, ISO 13485, ISO 14971). Development and execution of unit, sub-system and system-level test plans. Supporting software integration with hardware ...

middleware, firmware and algorithm development. Writing well-documented, maintainable, and test-driven code in line with medical device & industry specific standards (e.g. IEC 62304, ISO 13485, ISO 14971). Development and execution of unit, sub-system and system-level test plans. Supporting software integration with hardware ...

Salisbury area is essential. Keywords Software Validation Engineer, Validation Engineer, QA Engineer, Software Test Engineer, Regulated Environment, Pharmaceutical Engineering, Medical Devices, Industrial Automation, Compliance, ISO 9001, ISO 13485, Software Testing, Test Documentation, Traceability, SDLC, Quality Engineering, Automation Testing, Test Protocols, Validation Reports, Salisbury Jobs, Hybrid Engineering Roles. ...

etc.). Liaising with R&D department in the testing of new products. The Person: The ideal applicant will have worked to ISO 13485/MDR standards, we will look applicants who have worked at other highly accredited industries (aerospace/NADCAP, automotive etc) Minimum ISO ...

excellent written and verbal communication abilities. Qualifications Minimum of five years' experience in a medical manufacturing environment. In-depth knowledge of Quality Management Systems, ISO 13485, and 21 CFR 820. Proficient in IT, with strong skills in Microsoft Office applications. Familiarity with Good Documentation Practises (GDP) and Good ...

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 ...

development Collaborate with external vendors/suppliers Support documentation required for testing You will bring the following Hands on software engineering within a ISO13485 environment Experience in full stack development across Azure Previous background in web and and cloud technologies BSc or MSc in a relevant Life Sciences subject ...

Documentum & Learn4U . Requirements for the role: 5 or more years experience in a medical manufacturing environment In depth knowledge of Quality Management Systems, ISO 13485, 21 CFR 820 IT literate with strong knowledge of Microsoft Office packages. GDP & GMP (Good Documentation Practices & Good Manufacturing Practices ...

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 ...

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 ...