26 to 50 of 85 ISO 13485 Jobs in the UK

Take ownership of our medical device regulatory roadmap, working with external specialists and internal teams to progress our Class IIa ambitions, including classification, registration, ISO 13485 readiness, technical documentation and post-market surveillance. Ensure requirements are understood, work is prioritised and progress is driven through to completion. Coordinate … ideally involving Software as a Medical Device (SaMD) and Class IIa requirements. Quality management: Experience implementing, maintaining and improving a Quality Management System, including ISO 9001 and ideally ISO 13485. Data protection and international privacy regulation: Strong working knowledge of UK and EU GDPR, with practical experience managing ...

healthcare partners to deploy continuous clinical-safety assurances across UK healthcare settings. The role prioritises practical risk management, regulatory knowledge (DCB0129/DCB0160, ISO 14971, ISO 13485), and collaboration with vendors and providers to ensure safe #J-18808-Ljbffr ...

Support system integration testing, coordinating test execution across hardware, firmware, and software components and documenting integration test outcomes Contribute to risk management activities under ISO 14971, including review of FMEAs and verification of risk control effectiveness Develop and maintain test infrastructure, fixtures, calibration status and tooling needed to execute … Clear and precise technical writing skills, with experience authoring test protocols and reports that meet regulatory documentation standards Nice to have: Working knowledge of ISO 14971 and ISO 13485 applied to product design and development Experience with hardware‐in‐the‐loop or software‐in‐the‐loop testing ...

decisions Interest or experience in scientific software, instrumentation, FPGA programming, or advanced medical and life science technologies; familiarity with relevant regulatory frameworks (e.g., GAMP5, ISO 13485, IEC 62304, ISO 26262) and coding standards (e.g., MISRA C), including regulatory documentation, is an asset #LI-KM1 #LI-Onsite STEMCELL … development opportunities. STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact. As an equal opportunity employer, STEMCELL is dedicated to ensuring that every ...

successful in this role, you will ideally have: Experience within Medical Devices, Diagnostics or another highly regulated manufacturing environment. Strong knowledge of ISO 13485 and Quality Management Systems. Experience managing CAPAs, non-conformances, complaints and root cause investigations. Knowledge of quality tools such as 8D, 5 Why, Fishbone … process improvement initiatives. Exposure to supplier quality, change control and risk management activities. Strong documentation and problem-solving skills. Experience with Technical Documentation, ISO 14971, UK MDR, EU MDR, Design Controls or validation activities would be advantageous. Excellent stakeholder management and communication skills. Please note: sponsorship is not available ...

need to succeed You will have: Previous Quality Engineering experience within medical devices or another highly regulated manufacturing environment Strong knowledge of ISO 13485 and medical device quality systems Experience managing non-conformances, CAPA and root-cause investigations Knowledge of quality tools such as 8D, 5 Why, Fishbone … Good knowledge of UK MDR and EU MDR, particularly Technical File generation, maintenance or remediation A relevant engineering, scientific or technical qualification Experience with ISO 14971, design controls, process validation, complaint handling, supplier quality or internal auditing would be advantageous. What you'll get in return You will receive ...

DevOps, Zephyr Experience in the use of automated test software tools such as Ranorex, Playwright, Selenium, Test Complete Knowledge of IEC 62304 software lifecycle, ISO 14971 risk management, ISO 13485 quality systems and IEC 62366-1 usability engineering or comparable standards for other regulated sectors. #J ...

part of the role Experience of line management, supervision or mentoring of technical, manufacturing or workshop-based staff Desirable Criteria Experience of quality auditing, ISO 9001, 13485, or similar, supplier management, line management or regulated manufacturing environments Experience of CAD, rapid prototyping, product development and collaboration with design ...

technical stakeholders. Desirable Experience supporting software products through regulatory submissions, inspections, audits, or product approvals. Familiarity with standards and regulations such as IEC 62304, ISO 13485, FDA software guidance, EU IVDR, IEC 81001-5-1, or comparable industry frameworks. Familiarity with secure software development practices, vulnerability management, Software ...

Ranorex, Playwright, Selenium, Test Complete Ability to develop source code/scripts with at least one programming language. Knowledge of IEC 62304 software lifecycle, ISO 14971 risk management, ISO 13485 quality systems and IEC 62366-1 usability engineering or comparable standards for other regulated sectors. #J ...

team High attention to detail and ability to multi-task Initiative driven and deadline focusedCommitment to Health & Safety standards Performance Standards BS EN ISO 9001 – Quality Management Systems BS EN ISO 13485 – Medical Devices Quality Management IPC-A-610 – Acceptability of Electronic Assemblies AS9100 – Aerospace Quality Management ...

room HVAC system and all associated filtration and ducting to ensure the clean room remains compliant to ISO7 standard in accordance with BS EN ISO 14644. Recruit, train and mentor a small team of maintenance technicians, when required, to be competent in all clean room and equipment maintenance activities. … systems designed to function within an ISO7 clean room. Experience of working within an organisation certified to one or more of the following standards: ISO 9001, AS 9100, ISO 13485, IATF 16949. Proficiency in Microsoft Office (or equivalent), for using spreadsheets and generating written documents. Ability ...

Legal & Regulatory Affairs and collaborating with Engineering, you’ll ensure medical software meets global device standards. You will drive design control per IEC 62304, ISO 14971 and ISO 13485, translating complex rules into practical processes for engineers and product teams, and supporting audits and regulatory submissions. #J ...

room HVAC system and all associated filtration and ducting to ensure the clean room remains compliant to ISO7 standard in accordance with BS EN ISO 14644. Recruit, train and mentor a small team of maintenance technicians, when required, to be competent in all clean room and equipment maintenance activities. … systems designed to function within an ISO7 clean room. Experience of working within an organisation certified to one or more of the following standards: ISO 9001, AS 9100, ISO 13485, IATF 16949. Proficiency in Microsoft Office (or equivalent), for using spreadsheets and generating written documents. Ability ...

layouts, assembly drawings, BOMs and work instructions. A good understanding of electronics manufacturing quality standards and processes . Ideally, experience working within an ISO 9001 and/or ISO 13485 environment. Excellent attention to detail and good manual dexterity when handling small electronic components. Basic ...

fast-paced startup environment. Greatly Beneficial Safety-Critical Design: Experience designing for safety-critical systems or high-reliability applications-especially under standards such as ISO 26262 (automotive), IEC 61508 (industrial), or medical device standards (ISO 13485/IEC 60601/IEC 62304). Mixed-Signal Integration: Practical ...

considerations and design-for-manufacture principles. Experience with electronic testing tools such as oscilloscopes, spectrum analysers, and logic analysers. Understanding of medical device standards (ISO 13485, IEC 60601, IEC 62304) is an advantage. Ability to troubleshoot and solve complex design issues. Effective communication skills for working within cross ...

within a small team. Strong analytical and organisational skills. PREFERRED JOB REQUIREMENTS Knowledge of Lean Manufacturing, Six Sigma, or continuous improvement methodologies. Familiarity with ISO quality management systems. ISO 9001, 13485, 14001 Familiarity with statistical process control (SPC) and process validation. Experience with automation, robotics, or advanced ...

bring The essentials: Degree in Electronics Engineering, Electrical Engineering, or related discipline. Proven experience in electronics design for medical or regulated devices (ISO 13485 environment preferred). Proficiency in Altium Designer for schematic capture and multi‐layer PCB layout. Strong understanding of STM32 microprocessors, BLE, power/battery … Familiarity with DFM/DFT principles and working with contract manufacturers. Understanding of wireless regulatory testing (CE/FCC) and EMC design. Knowledge of ISO 14971 risk management and medical device development processes. Embedded systems development experience. Why Neupulse? Make a tangible difference. Your work on cutting‐edge wearable ...

access management and continuous improvement. Develop, maintain and improve manufacturing software systems, electronic records, reporting tools and digital workflows in compliance with GMP, FDA, ISO 13485, 21 CFR Part 11 and applicable regulatory requirements. Lead Computer System Validation (CSV) activities, including the development and execution of Validation Plans ...

. Qualifications: Degree in Mechanical, Electrical, Mechatronics, or Automation Engineering (or equivalent hands-on experience). Pluses: Robotics integration (6-axis/SCARA), ISO 13485/GAMP knowledge, or Six Sigma training. ...

systems engineering, quality, and regulatory affairs to ensure smooth execution. Alignment of development activities with industry standards and regulatory frameworks such as FDA requirements, ISO 13485, IEC 62304, CLIA, and data privacy regulations. Facilitation of Agile or hybrid delivery models tailored to the needs of regulated product development. ...

support in a pro-active manner in the form of creative solutions to problems encountered with the product. To deliver work in compliance with ISO13485 and FDA Medical Device Design Control processes. MINIMUM QUALIFICATIONS Strong academic background (2:1 Degree) in Electronic Engineering or equivalent education gained through work experience. ...

engineering (e.g., Systems, Biomedical, Mechatronics, Electronics) or related discipline. 5+ years’ experience in a regulated industry where Quality Systems are essential, e.g., ISO 13485. Expert knowledge of microcontrollers, embedded firmware development/debugging of scripts and programs. Experience of using CAD software (e.g., Altium, SolidWorks) for electromechanical designs towards ...

framework. Training and mentoring junior members of the team. Promote automation-first thinking within the testing team. Compliance with the MDD/MDR and ISO 13485/62304 standards for validation and verification of software medical devices. Skills & Experience Required: Essential Strong Python programming skills, including object-oriented ...