7 of 7 ISO 13485 Jobs in the South West

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 More ❯

Prototyping : Hands-on experience with miniaturization, waterproofing, and creating robust electronics for wearable devices. MedTech Regulatory Standards : Knowledge of medical device regulatory standards (e.g., ISO 13485, FDA) and experience in compliance testing. Sensor Integration : Familiarity with various biosensor technologies, including electrochemical sensors used in wearable health devices. Wearable More ❯

Expertise in plastics materials and processing (e.g., injection molding, extrusion, ultrasonic welding, UV/solvent bonding, sterilization). Knowledge of FDA Design Controls and ISO 13485 Quality Management Systems. Proficiency in CAD design and PDM software (e.g., Creo, SolidWorks). Understanding of ANSI/AAMI/ISO 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. ISO 13485, MDR) is a bonus. A natural collaborator and communicator, able to bridge technical and clinical perspectives. Following your application, Mark Njiriri , a More ❯

and third parties to maintain and improve product quality. Key Responsibilities: Take full responsibility in maintaining the Quality Management System (QMS) ensuring compliance with ISO 13485. Ensure that technical documentation (where appropriate) conforms with audit requirements. Manage documentation and reporting for non-conformances (NCR), deviations and complaints. Act as … all team members. Experienced required: previous experience of Quality Management/Quality Assurance Management in a fast-paced manufacturing environment (Essential). Knowledge of ISO 13485 (Desirable). Experience of working with regulatory bodies. Hands-on problem-solving skills with a focus on efficiency and quality. Excellent computer More ❯

Engineering, or a related engineering field. At least 5 years' experience in health-care or molecular engineering with demonstrated experience with FDA QSR and ISO 13485. Experience developing products in an IVD diagnostic development, including the use of statistics in experimental design. Strong understanding of mechanical, electronic, and software More ❯

Systems Engineering or related engineering field. At least 10 years' experience in health-care or molecular engineering with demonstrated experience with FDA QSR and ISO 13485. Experience developing products in an IVD diagnostic development, including use of Statistics in experimental design. Strong understanding of mechanical, electronic and software design More ❯