1 to 25 of 28 ISO 13485 Jobs in the UK excluding London

tools and environment. Suggests changes to current Optos systems to improve efficiency and quality of software development. All activities to be carried out in compliance with the Optos SDLC, ISO13485 and FDA Medical Device Design Control processes. MINIMUM QUALIFICATIONS Educated to degree level in a software engineering discipline or equivalent education gained through work experience. 5+ years' experience in designing More ❯

team. Own the codebase – Drive full lifecycle development of embedded software (C/C++, RTOS, bare-metal systems). Set the standards – Ensure compliance with industry regulations (IEC 62304, ISO 13485, etc.). Collaborate globally – Work alongside electronics, systems, quality, and R&D teams to deliver world-class products. Innovate and evolve – Promote best practices, continuous improvement, and More ❯

embedded software team.Own the codebase - Drive full lifecycle development of embedded software (C/C++, RTOS, bare-metal systems).Set the standards - Ensure compliance with industry regulations (IEC 62304, ISO 13485, etc.).Collaborate globally - Work alongside electronics, systems, quality, and R&D teams to deliver world-class products.Innovate and evolve - Promote best practices, continuous improvement, and cutting-edge More ❯

subsystem architects and external partners, while managing technical debt and prioritizing customer-centric non-functional requirements. Ensure software compliance with medical regulatory standards like FDA, MDR, IEC 62304 and ISO 13485.Maintain comprehensive documentation to support regulatory submissions, audits, and compliance reviews. Collaborate with global R&D teams and stakeholders in marketing, PMO, quality, regulatory, and service functions.Serve as a … teams in multiple product launches. Your skills include a strong background in clinical applications, systems integration, interoperability, and knowledge of medical device regulations like IEC 62304, FDA, MDR, and ISO 13485.You are familiar to work in agile development methodologies like SAFe, apply AI/ML technologies, and are able to solve problems using modern C++ code. You have a More ❯

level driver development. Strong understanding of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO 13485, FDA guidelines) is highly preferred. More ❯

or related field (or equivalent work experience). Previous experience in a fast-paced PCB fabrication environment required. Familiarity with quality systems such as ISO 9001, AS9100 or ISO13485 is a plus. If you are passionate about leading teams in a dynamic environment and possess the necessary skills, we encourage you to apply for this exciting opportunity as a More ❯

Engineer. In this role you will play a key part in our Quality Team, reporting to the Head of Quality, responsible for the maintenance of the quality system to ISO 13485 standards and associated product certification. As a Quality Systems Engineer, you will: Support the maintenance and continuous improvement of our ISO 13485 compliant Quality Management … audits. Analyse quality data and contribute to process improvement initiatives. Required experience: 2+ years of experience in a Quality role within the medical device industry Hands-on knowledge of ISO 13485 and 21 CFR 820 Strong attention to detail and problem solving skills Ability to work as part of a multi-disciplinary, fast-paced diverse team Ability to More ❯

Description Job Posting Description In this role, you have the opportunity to Be involved in the development of Philips CDS software, within the Tools team. In compliance with the ISO standards applied to the medical sector (ISO 13485), you will participate in the creation of tools used by our development teams. You will propose a technical design … inclusion here . Rattaché au responsable du développement, vous intervenez sur le développement des logiciels de Capsule Technologie au sein de l'équipe Tools. Dans le respect des normes ISO appliquées au médical (ISO 13485), vous participerez à la réalisation des outils utilisés par nos équipes de développement. Vous proposez un design technique, vous écrivez le code More ❯

Comfortable working in a small, fast-paced, and collaborative environment. Proficiency in project management tools (e.g., MS Project, Jira, Confluence, or equivalent). Familiarity with regulated environments (such as ISO 13485) is a plus. Desirable Experience in optical systems, ophthalmic devices, or AR/VR hardware. Project management certification (e.g., PMP, Prince2, Agile/Scrum). Experience balancing More ❯

procedures, identify instrument/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 levels under a various conditions. … team measures, facilitating and driving 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 (E/D): Degree/HND science/engineering basis; Chemistry, Physics, Biological, Electronics More ❯

lead Computer Systems Validation across the site and support the execution of the Validation Master Plan. You will ensure compliance with regulatory requirements (21 CFR Parts 11, 211, 600, ISO 9001, ISO 13485) and provide guidance on validation issues. Your responsibilities will include participating in investigations for failures, managing CAPA, and driving continuous improvement initiatives while maintaining More ❯

and product validation, iterating based on test results and feedback. Collaborate with suppliers on design reviews, ensuring cost-effective, reliable manufacturing. Ensure compliance with relevant regulatory and quality standards (ISO 9001, CE, RoHS, EMC considerations). Support root cause analysis and continuous improvement (CI) activities during and post NPI. Document processes and design changes, maintaining alignment with engineering change … understanding of DFM/DFA principles. Ability to work closely with cross-functional teams (electronics, firmware, quality, production). Experience in risk assessment, FMEA, and quality documentation aligned with ISO 9001 or similar. Comfort with prototyping, debugging, and iterative design. Nice to Have Experience in RFID/NFC, barcode scanners, or imaging devices mechanical design. Familiarity with ISO 13485, ISO 14971, or similar regulated environments. Exposure to Lean Manufacturing, Six Sigma methodologies. Experience designing test fixtures for production and QA. Familiarity with IP rating considerations for rugged devices. Why us? Work on real hardware products that ship globally. See your designs in use in airports, banks, and secure environments worldwide. Join a collaborative, engineering-led More ❯

My client is a leading AS9100 and ISO 13485 accredited UK contract electronics manufacturer with over 30 years' experience based in Luton, Bedfordshire. They work within a range of industry sectors with vastly experienced and qualified staff offering tailored bespoke solutions to all their clients. Why Join? They have a total of 100 staff members across the UK More ❯

SQL Experience working with data lakes, warehouses, and large-scale datasets Understanding of data privacy and security principles Exposure to life sciences, genomics, or regulated medical environments (such as ISO 13485) or significant work within this sector/environment Comfortable working across both on-premise and cloud-based data systems Clear communicator, able to translate complex data concepts More ❯

SQL Experience working with data lakes, warehouses, and large-scale datasets Understanding of data privacy and security principles Exposure to life sciences, genomics, or regulated medical environments (such as ISO 13485) or significant work within this sector/environment Comfortable working across both on-premise and cloud-based data systems Clear communicator, able to translate complex data concepts More ❯

team of engineers across multiple disciplines (mechanical, electrical, software, systems) Oversee the design, development, testing, and validation of innovative medical devices in accordance with regulatory standards (e.g. FDA, CE, ISO 13485) Drive project execution, ensuring timely delivery, budget adherence, and product quality. Collaborate cross-functionally with R&D, Quality, Regulatory, and Project teams to align engineering efforts with More ❯

a Quality Assurance Specialist to join a leading pharmaceutica logistics company. This role focuses on supporting the implementation and maintenance of the Quality Management System (QMS) in line with ISO 9001 and ISO 13485 standards, and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements. … Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong knowledge of GDP, GMP, ISO 9001, and ISO 13485 standards. Excellent organizational, communication, and stakeholder management skills. More ❯

a Quality Assurance Specialist to join a leading pharmaceutica logistics company. This role focuses on supporting the implementation and maintenance of the Quality Management System (QMS) in line with ISO 9001 and ISO 13485 standards, and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements. … Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong knowledge of GDP, GMP, ISO 9001, and ISO 13485 standards. Excellent organizational, communication, and stakeholder management skills. More ❯

to work in the UK Genedrive is a pioneering medical device company headquartered in Manchester, focused on developing innovative molecular diagnostic solutions that improve patient outcomes worldwide. Certified to ISO 13485:2016 and operating in compliance with BS EN ISO 14971 and IEC 62304, Genedrive is dedicated to meeting the highest standards in medical technology. With a … Degree-qualified in a science or engineering discipline Minimum 3 years of experience in a QA/RA role within the IVD or medical device sector Solid understanding of ISO 13485 and ISO 14971 Experience with internal/external audits and training delivery Excellent analytical, organisational, and communication skills Comfortable working independently and within cross-functional teams … Desirable: Knowledge of IEC 62304, ISO 60601, and global radio regulations Experience with global medical device regulations particularly UK, EU and USA Familiarity with the commercialisation of IVD products ISO 13485:2016 Lead Auditor training This role is a unique chance to step into a high-impact position within a fast-moving and rewarding sector, apply now More ❯

Requirements: 2 3 years experience in sales or business development within electronics Demonstrable success in driving new business Excellent communication and negotiation skills Familiarity with ISO9001 and/or ISO13485 Full UK driving licence Ability to travel to East Kent 3 times per week Looking for a role where you can make a real impact? Apply now. Morgan Jones is More ❯

to continual process improvement across the business. Responsibilities as a Quality Systems Engineer in Andover. Develop and maintain the Business Management System and supporting software platform. Ensure compliance with ISO 9001, AS 9100, ISO 13485, and related standards. Conduct investigations using 8D, Ishikawa, and 5WHY methodologies. Lead or support internal audits and prepare for certification, regulatory, and … system performance. Requirements as a Quality Systems Engineer in Andover. 3+ years of experience in quality management within manufacturing or product development. Strong working knowledge of ISO9001, AS 9100, ISO13485, and ISO14001. Degree in Electrical or Mechanical Engineering (or equivalent experience). If you are interested in this Quality Systems Engineer job in Andover. then APPLY NOW. More ❯

maintaining a strong focus on customer satisfaction. Maintain organised records and ensure all documentation is archived in line with company policies. Follow all relevant procedures and quality standards, including ISO13485, ISO14001, and Medical Device Regulations. Engage in continuous improvement by completing all required training and Learning Management System (LMS) modules on time. Qualifications and Experience: Must be educated to a … at least 2 years' proven experience in a similar role. Excellent communication skills (written and verbal). Experience with SAP and Salesforce is highly desirable. Experience working in an ISO 13485 , 14001 and MDR regulated environment is desirable. Skills: IT Skills including the ability to use Microsoft Office at a proficient level. Good English in verbal and written More ❯

worker with a flexible schedule and a commitment to excellence. Full UK driving licence and a readiness to travel regularly across the UK. Familiarity with quality standards such as ISO 13485 or CE/UKCA is a plus. What's on Offer A highly competitive salary tailored to your experience and expertise. Performance-based bonus structure to reward More ❯

worker with a flexible schedule and a commitment to excellence. Full UK driving licence and a readiness to travel regularly across the UK. Familiarity with quality standards such as ISO 13485 or CE/UKCA is a plus. What's on Offer A highly competitive salary tailored to your experience and expertise. Performance-based bonus structure to reward More ❯

worker with a flexible schedule and a commitment to excellence. Full UK driving licence and a readiness to travel regularly across the UK. Familiarity with quality standards such as ISO 13485 or CE/UKCA is a plus. What's on Offer A highly competitive salary tailored to your experience and expertise. Performance-based bonus structure to reward More ❯