system (QMS) ensuring compliance with regulatory requirements and supporting regulatory submissions. The successful candidate should have a strong background in regulatory standards such as ISO13485, to ensure quality and regulatory adherence in our product development and implementation. They should have experience managing the QMS, conducting internal and … external audits and implementing CAPA processes to drive continuous improvement. A solid understanding on risk management (ISO 14971), validation (IQ, OQ, PQ) and GCLP principles is essential. The candidate must possess strong problem-solving skills, attention to detail, the ability to work autonomously and have excellent interpersonal skills to … person, at least 3 times a week, during typical working hours. This role will also require occasional travel owing to international lab setup. Responsibilities ISO13485 compliance and quality management system (QMS) maintenance Ensure full compliance with ISO13485:2016 standards. Oversee, manage and improve the More ❯
system (QMS) ensuring compliance with regulatory requirements and supporting regulatory submissions. The successful candidate should have a strong background in regulatory standards such as ISO13485, to ensure quality and regulatory adherence in our product development and implementation. They should have experience managing the QMS, conducting internal and … external audits and implementing CAPA processes to drive continuous improvement. A solid understanding on risk management (ISO 14971), validation (IQ, OQ, PQ) and GCLP principles is essential. The candidate must possess strong problem-solving skills, attention to detail, the ability to work autonomously and have excellent interpersonal skills to … person, at least 3 times a week, during typical working hours. This role will also require occasional travel owing to international lab setup. Responsibilities ISO13485 compliance and quality management system (QMS) maintenance Ensure full compliance with ISO13485:2016 standards. Oversee, manage and improve the More ❯
Software Engineer, Quality, IEC 62304, ISO13485, Medical Devices, COR7184 A rare and exciting opportunity has arisen for a Software Engineer with experience working with software as a medical devices and IEC 62304 standards, to join a pioneering scientific R&D company specialising in the development of medical … Diagnostic products. Working alongside a highly skilled team, you'll be responsible for implementing and maintaining SDLC processes, software risk management, and compliance with ISO13485, IEC 62304, and 21 CFR Part 820. This is a fantastic opportunity to make a significant impact in a fast-growing company … Engineer? Experience defining, implementing, and maintaining Software Development Life Cycle (SDLC) processes Proven experience in software quality engineering and risk management Strong knowledge of ISO13485, IEC 62304, 21 CFR Part 820, IVDR Experience in software security risk management (SW:96:2023, ISO 27001, IEC 80001) is More ❯
years of experience in quality management within the medical device industry. Experience with implementing and maintaining Quality Management Systems (QMS) in accordance with ISO standards. Knowledge of ISO Standards including ISO13485, ISO 9001, ISO 14971, IEC 62304, and EN 60601. Knowledge of global … Auditing is a plus. Experience with tools like SharePoint, Confluence, and Jira. Key Responsibilities: Create, implement, and maintain the Quality Management System (QMS) following ISO 9001, ISO13485, UK MDR 2002, and (EU) MDR 2017/745. Lead internal audits, assist with external audits, and ensure issues More ❯
Quality Assurance Engineer - Medical Device (MDR ISO13485) Location : Leeds Salary: Up to £50,000 Are you a passionate and detail-oriented Quality Assurance professional with an interest in working on a complex medical device? We are seeking a dedicated Quality Assurance Engineer to become the expert in … edge medical device while receiving training to thrive in the position. Key Responsibilities: Oversee the implementation and adherence to MDR (Medical Device Regulation) and ISO13485 in the development of medical devices. Ensure all quality assurance processes align with the latest medical regulation requirements, focusing on MDR compliance. … Create and manage standard operating procedures (SOPs), documentation, and reports in line with 13485 standards. Conduct regular audits, inspections, and testing of medical devices to ensure they meet both MDR and ISO13485 requirements. Support the creation and maintenance of documentation related to regulatory submissions and quality More ❯
and Goods Inwards. Assist in day to day running of the customer RMA process. Preparing PPAP and FAIR reports. Assisting in maintaining ISO9001, and ISO13485 Quality management standards. Carrying internal audits as per ISO 9001 and ISO13485 standards. Assist in supplier quality assurance … problem solving methods like 8D, fishbone, 5Whys, etc. Practical experience of PFMEA, Process Maps and Quality Control Plans. Experience in PPAP and FAIRs. Internal ISO 9001 auditor Demonstrable people and project management skills. Able to understand the basics of technical drawings, measurements, and tolerances. Experienced with using MS Excel … Willing to learn from mistakes and handle constructive criticism positively. Significant advantages Experience in electronic manufacturing, particularly PCB manufacturing. Experience with ISO14001 Experience with ISO13485 Experience with ISO 27001. Lead ISO 9001 auditor Six-sigma green belt Lean manufacturing Qualifications Essential A suitable college-level qualification (A-level More ❯
Software Engineer, Quality, IEC 62304, ISO13485, Medical Devices, COR7184 A rare and exciting opportunity has arisen for a Software Engineer with experience working with software as a medical device and IEC 62304 standards, to join a pioneering scientific R&D company specialising in the development of medical … Diagnostic products. Working alongside a highly skilled team, you’ll be responsible for implementing and maintaining SDLC processes, software risk management, and compliance with ISO13485, IEC 62304, and 21 CFR Part 820. This is a fantastic opportunity to make a significant impact in a fast-growing company … Engineer? Experience defining, implementing, and maintaining Software Development Life Cycle (SDLC) processes Proven experience in software quality engineering and risk management Strong knowledge of ISO13485, IEC 62304, 21 CFR Part 820, IVDR Experience in software security risk management (SW:96:2023, ISO 27001, IEC 80001) is More ❯
and Goods Inwards. Assist in day-to-day running of the customer RMA process. Prepare PPAP and FAIR reports. Assist in maintaining ISO9001 and ISO13485 Quality management standards. Conduct internal audits as per ISO 9001 and ISO13485 standards. Assist in supplier quality assurance … solving methods like 8D, fishbone, 5 Whys, etc. Practical experience of PFMEA, Process Maps, and Quality Control Plans. Experience in PPAP and FAIRs. Internal ISO 9001 auditor. Demonstrable people and project management skills. Able to understand the basics of technical drawings, measurements, and tolerances. Experienced with using MS Excel … from mistakes and handle constructive criticism positively. Significant advantages Experience in electronic manufacturing, particularly PCB manufacturing. Experience with ISO14001. Experience with ISO13485. Experience with ISO 27001. Lead ISO 9001 auditor. Six-sigma green belt. Lean manufacturing. Qualifications Essential A suitable college-level qualification (A-level, BTEC, C&G More ❯
An interest in healthcare, software, or quality/compliance - A degree (or equivalent), or relevant experience in administration, finance, or customer support - Experience with ISO-certified systems (such as ISO13485, ISO 27001, or ISO 9001) is desirable This role might particularly suit someone with More ❯
in our medical technology meets the highest quality and regulatory standards. Responsibilities: Develop, implement, and maintain software quality assurance (QA) processes in compliance with ISO13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR. Lead software validation and verification (V&V) activities, including test planning, execution … and documentation. Collaborate with software engineers to ensure software development lifecycle (SDLC) compliance, including risk management (ISO 14971) and cybersecurity considerations. Support regulatory submissions (e.g., FDA 510(k), CE marking) by preparing software-related documentation such as Software Development Plans, Software Design History Files (DHF), and Software Bill of … effectively addressed and documented. Skills & Experience: Demonstrable experience in QA/RA for software in medical devices or a related field Strong knowledge of ISO13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations for software Experience with software validation, V&V testing, and risk More ❯
seeking to recruit an experienced Quality Systems Engineer to complement their professional Quality Division. Reporting to the Quality Manager and working in an ISO9001, ISO13485, ISO14001 and IATF16949 accredited environment based near Dudley, the successful candidate will be tasked with developing the Quality strategy, policies, processes, standards and systems within … knowledge of quality and business systems and strong knowledge of APQP, PPAP and FMEA, along with Lean Manufacturing/Six sigma and ITAF 16949, ISO13485, ISO 9000, gained within a high volume manufacturing environment. You will demonstrate a good understanding of engineering drawings and manufacturing processes … measurement and quality assurance, with knowledge of both ISO 27001 and ISO14001 and Health and Safety Practices gained in an automotive environment proving distinctly advantageous. Contact the Quality Team at Premier Technical Recruitment on 01827 68400 or email your cv in confidence to for further details. More ❯
sitting outside IR35. As a Senior Engineering Technician, you’ll play a hands-on role in troubleshooting, maintaining, and optimising specialised instruments within an ISO13485-compliant setting. From supporting R&D teams to managing your own technical projects, this is an opportunity to contribute directly to innovation … input and collaborating with engineers and scientists across multi-disciplinary teams. Drafting and maintaining high-quality documentation (SOPs, BOMs, WIs, reports) in line with ISO13485 regulations. Independently managing tasks and small projects with minimal supervision. What we’re looking for in a Senior Engineering Technician: Proven experience More ❯
with IoT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc). Experience of working within a Quality System ideally EN ISO13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience : Degree in Electronics Engineering. At least More ❯
Experience with IOT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc) Experience of working within a Quality System ideally EN ISO13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience : Degree in Electronics Engineering. At least More ❯
with IoT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc.). Experience of working within a Quality System ideally EN ISO13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience : Degree in Electronics Engineering. At least More ❯
Harwell, England, United Kingdom Hybrid / WFH Options
OPD (Oxford Product Design)
CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯
Harwell, midlands, united kingdom Hybrid / WFH Options
OPD (Oxford Product Design)
CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯
harwell, south east england, united kingdom Hybrid / WFH Options
OPD (Oxford Product Design)
CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯
the release process. Ensure compliance with regulatory or internal change management policies, including experience with standards surrounding software as a medical device, for example ISO13485 and ISO 62304. Test Automation Maintain best practices for release management, such as CI/CD (Continuous Integration/Continuous Deployment More ❯
and reliable medical devices. Responsibilities: Software Development: Design and develop software for medical devices while ensuring compliance with industry standards such as IEC 62304, ISO 14971, IEC 62366, ISO13485, and FDA regulations, including cybersecurity requirements Implementation & Compliance: Develop software solutions and support cross-functional development activities More ❯
medical devices. Responsibilities: Software Development: Design and develop the GUI software for medical devices while ensuring compliance with industry standards such as IEC 62304, ISO 14971, IEC 62366, ISO13485, and FDA regulations, including cybersecurity requirements. Implementation & Compliance: Develop software solutions and support cross-functional development activities More ❯
and internal tools Verification and Validation: Lead formal Software Verification and Validation (V&V) activities, ensuring adherence to industry standards such as IEC 62304, ISO 14971, IEC 62366, ISO13485, and FDA regulations, including cybersecurity requirements Process Improvement: Drive continuous improvement by enhancing automation, adopting innovative testing More ❯
the technical deliverables. Conduct functional and non-functional testing. Software development is to be undertaken in accordance with industry standards and working within an ISO13485 quality management system relevant to a class 2b device under IEC 62304, IEC (phone number removed) and IEC (phone number removed) Person More ❯
Kensington and Chelsea, Greater London, Colville, United Kingdom
NuTissu ltd
the technical deliverables. Conduct functional and non-functional testing. Software development is to be undertaken in accordance with industry standards and working within an ISO13485 quality management system relevant to a class 2b device under IEC 62304, IEC (phone number removed) and IEC (phone number removed) Person More ❯
their needs and expectations, and providing IT support and guidance. Ensure compliance with the regulations and standards of the medical devices market, such as ISO13485, FDA, and MDR. Monitor and report on the IT performance and budget in the country, identifying risks and opportunities for improvement. Skills More ❯
