1 to 25 of 30 Permanent ISO 13485 Jobs in the UK excluding London

opportunity for a Quality Assurance Manager to join them on a permanent basis. As their new QA Manager, you will be responsible for leading Quality Assurance, ensuring compliance with ISO 13485, FDA 21 CFR Part 820 and other applicable international regulations. This is a key leadership role, managing the QA team, driving a culture of compliance, and ensuring … strategic and operational quality objectives. Key Responsibilities Lead and develop the QA team, managing performance, training, and mentoring. Maintain and continually improve the Quality Management System in compliance with ISO 13485, FDA QSR, EU MDR and other applicable standards. Oversee internal and external audits, including hosting regulatory inspections. Manage CAPA, NCR, and root cause analysis processes, ensuring timely … monitoring. Experience and Skills Required 5+ years of Quality Assurance experience within the Medical Device sector. Minimum of 2 years in a managerial or leadership role. Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820 and EU MDR. Experience hosting regulatory inspections and leading internal audits. Proven leadership skills with the ability to influence 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 ❯

with the quality/regulatory team to ensure customer complaints, feedback, incidents and notifiable events are handled in accordance with the company's procedures for post-market surveillance (under ISO 13485 and EU MDR). Work closely with the software, firmware, hardware, operations and quality teams to resolve technical issues promptly and to ensure a positive customer experience … or other relevant data-oriented discipline (or equivalent industrial experience) Experience working with medical devices that include a software or firmware component Experience working within a quality management system (ISO 13485 or ISO 9001), or in a regulated industry Industrial experience as Tier 2 or 3 Technical Support Engineer or similar role Experience in an early-stage More ❯

maintain firmware for embedded systems using STM32 microcontrollers Implement and optimise RTOS (FreeRTOS) and embedded communication protocols (Bluetooth BLE, I2C) Ensure compliance with relevant industry standards including IEC 62304 & ISO 13485 Collaborate with cross-functional teams including hardware, software, and regulatory Lead firmware reviews, debug issues, and drive performance and reliability improvements Maintain clear and thorough documentation across … Bluetooth BLE and serial communication protocols (e.g. I2C) Experience building firmware that interfaces with iOS/Android via BLE Knowledge of regulated environments and applicable standards (e.g. IEC 62304, ISO 13485) Familiarity with CI/CD pipelines, automated testing, and embedded cybersecurity This is a great opportunity for an experienced embedded systems engineer join a fast-growing MedTech More ❯

maintain firmware for embedded systems using STM32 microcontrollers Implement and optimise RTOS (FreeRTOS) and embedded communication protocols (Bluetooth BLE, I2C) Ensure compliance with relevant industry standards including IEC 62304 & ISO 13485 Collaborate with cross-functional teams including hardware, software, and regulatory Lead firmware reviews, debug issues, and drive performance and reliability improvements Maintain clear and thorough documentation across … Bluetooth BLE and serial communication protocols (e.g. I2C) Experience building firmware that interfaces with iOS/Android via BLE Knowledge of regulated environments and applicable standards (e.g. IEC 62304, ISO 13485) Familiarity with CI/CD pipelines, automated testing, and embedded cybersecurity This is a great opportunity for an experienced embedded systems engineer join a fast-growing MedTech More ❯

code from general requirements. Experience with IoT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc). Experience of working within a Quality System ideally EN ISO 13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience : Degree in Electronics Engineering. At least 3-5 years of industrial experience in More ❯

to proactively identify and mitigate risks. Work closely with the security team to integrate best practices into new and existing features. Ensure compliance with security standards and regulations (e.g., ISO 27001, SOC 2). Implement monitoring solutions to detect and respond to real-time security incidents. Troubleshoot infrastructure and security issues, performing root cause analysis in production. Mentor junior … cloud platforms (AWS, GCP). Experience with security tools like OWASP ZAP, Burp Suite, etc. Familiarity with Jira, Confluence, or similar tools. Knowledge of compliance frameworks (e.g., GDPR, HIPAA, ISO 27001, ISO 13485). Background in start-up or scale-up environments is a plus. Key Attributes: Strong collaboration skills. Eagerness to learn and upskill in new More ❯

STM32). Familiarity with RTOS, bare-metal, or embedded Linux environments. Professional experience utilising Docker containers. Experience with communication protocols (UART, SPI, I2C, USB). Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820. Strong understanding of software development lifecycle and version control (e.g., Git). Qualifications Bachelor's or Master's degree in computer 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 ❯

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 ❯

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 ❯

embedded, application, and UI layers. Own our full software stack - from real-time firmware to intuitive user interfaces. Introduce lean, agile development practices within a regulated framework (IEC 62304, ISO 13485). Build for extensibility - enabling third-party instrument development and open platform integrations. Collaborate cross-functionally with hardware, UX, clinical, regulatory, and quality teams. Manage and mentor … track record delivering full-stack systems, including RTOS-based firmware and application software. Deep knowledge of modular, scalable platform architecture. Strong grasp of compliance standards like IEC 62304 and ISO 13485. Excellent communication, problem-solving, and team-building skills. Experience leading teams and delivering in dynamic, mission-driven environments. Your Background: Degree-qualified in software engineering, computer science, electrical … engineering, or related discipline. Bonus points for direct experience with IEC 62304 or ISO 13485. Willingness to travel occasionally for labs or customer collaboration. Why Join Us? This is a rare opportunity to own the software backbone of a system with global clinical impact. At Creo, you'll help define the digital infrastructure powering the future of surgery - with 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 ❯

SCRUM is essential. If you're confident facilitating, coaching, and communicating across teams, you'll fit right in. You'll also need to be familiar with regulatory standards like ISO 13485, IEC 62304, and FDA's 21 CFR Part 820. Experience working on products that combine hardware and software is important, especially if you've delivered medical device More ❯

product engineering staff. Provide customer 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. Previous experience in electronics design 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 ❯

Oracle Cloud (OCI) or other cloud platforms (AWS, GCP). Experience with Jira, Confluence, or similar project management tools. Knowledge of compliance frameworks and standards (e.g. GDPR, HIPAA, ISO27001, ISO13485). Key Attributes: Collaborative mindset. Willingness to learn, cross-train, and upskill in new technology. Hands-on approach to exploring new technologies and developing proofs of concept (POCs). Strong More ❯

the product from design to manufacturing, solving engineering issues in electronics, firmware, and production instrumentation Maintain, adapt, and optimise existing firmware within the constraints of regulatory compliance (IEC 62304, ISO 13485) Lead electronics design, schematic capture, and PCB layout using Altium Develop LabVIEW applications for test and instrumentation Collaborate with manufacturing partners to troubleshoot and resolve production issues More ❯

the product from design to manufacturing, solving engineering issues in electronics, firmware, and production instrumentation Maintain, adapt, and optimise existing firmware within the constraints of regulatory compliance (IEC 62304, ISO 13485) Lead electronics design, schematic capture, and PCB layout using Altium Develop LabVIEW applications for test and instrumentation Collaborate with manufacturing partners to troubleshoot and resolve production issues More ❯

a small company environment Strongly Advantageous: Experience in optoelectronics, PID temperature control, and reliability testing Expertise in IVD/medical device compliance (EU & USA) Experience in regulated product development (ISO 13485, IVDR, 60601, EMC standards, FDA approvals) If you're ready to make a real impact, apply today! How to apply for the role: If you have the More ❯

a small company environment Strongly Advantageous: Experience in optoelectronics, PID temperature control, and reliability testing Expertise in IVD/medical device compliance (EU & USA) Experience in regulated product development (ISO 13485, IVDR, 60601, EMC standards, FDA approvals) If you’re ready to make a real impact, apply today! How to apply for the role: If you have the More ❯

ll need to apply: 4+ years in a data engineering or similar role, building and maintaining data pipelines Exposure to life sciences, genomics, or regulated medical environments (such as ISO 13485) or significant work within this sector/environment Exposure to genomic data formats and tools Exposure to GCP Strong experience with Python and SQL Experience working with More ❯

pragmatic, can-do attitude Comfortable working across teams in a fast-moving, multidisciplinary environment Well-organised, detail-oriented, and driven to see complex projects through to completion Experience with ISO 13485 or similar regulated manufacturing is a big plus Who you'll work with: Our Director of Cartridge Manufacturing and Programme Managers Cross functional teams including engineers, technicians More ❯

pragmatic, can-do attitude Comfortable working across teams in a fast-moving, multidisciplinary environment Well-organised, detail-oriented, and driven to see complex projects through to completion Experience with ISO 13485 or similar regulated manufacturing is a big plus Who you'll work with: Our Director of Cartridge Manufacturing and Programme Managers Cross functional teams including engineers, technicians More ❯

team environment. Key Duties and Responsibilities:- Regulatory To carry out engineering activities in accordance with company QA procedures and to meet regulatory regimes such as Medical Device Regulation (EU), ISO13485 (Int), FDA CFR820 (USA) and appropriate standards including IEC 60601, IEC 62304, ISO 14971 Software management Assignment and management of appropriate resources providing motivation, supervision and guidance of software More ❯