Waltham Abbey, Essex, South East, United Kingdom Hybrid / WFH Options
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supporting their commitment to quality, compliance, and continuous improvement, helping to safeguard the integrity of their products and processes. Drawing on your expertise in ISO 17025 and wider regulatory frameworks, you will take ownership of their Business System Manuals and Technical Documentation, ensuring they remain robust, up to date … and audit ready. As the Management Representative for ISO13485:2016, you will lead internal audits, monitor regulatory changes, and drive compliance initiatives across the business, working closely with teams to embed quality and regulatory best practices into everything they do. Whether maintaining technical documentation, leading management reviews … of all in-vitro diagnostic medical devices manufactured and sold by our client and manage all technical documentation. To act as management representative for ISO13485:2016. Requirements for this role: Demonstrable experience of ISO 17025 accreditation within a laboratory environment. Experience of ISO 9001, ISOMore ❯
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 ❯
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 ❯
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 ❯
noise reduction, spectral analysis). Comfortable navigating noisy real-world datasets and sensor limitations. Experience working within or adjacent to regulated medical environments (e.g. ISO13485, MDR) is a bonus. A natural collaborator and communicator, able to bridge technical and clinical perspectives. Following your application, Mark Njiriri , a More ❯
noise reduction, spectral analysis). Comfortable navigating noisy real-world datasets and sensor limitations. Experience working within or adjacent to regulated medical environments (e.g. ISO13485, MDR) is a bonus. A natural collaborator and communicator, able to bridge technical and clinical perspectives. Following your application, Mark Njiriri , a More ❯
noise reduction, spectral analysis). Comfortable navigating noisy real-world datasets and sensor limitations. Experience working within or adjacent to regulated medical environments (e.g. ISO13485, MDR) is a bonus. A natural collaborator and communicator, able to bridge technical and clinical perspectives. Following your application, Mark Njiriri , a More ❯
e.g., MATLAB, Python) Experience architecting complex medical or diagnostic devices, working across hardware, software, and mechanical disciplines Familiarity with regulatory and compliance frameworks (e.g., ISO13485, IEC 60601, FDA QSR) Understanding of design verification, validation, and risk management processes Practical knowledge of design-for-manufacture and design transfer More ❯
