1 to 7 of 7 ISO 13485 Jobs in Hampshire

including creating and implementing test plans. Maintain an appropriate working knowledge of medical standards including but not limited to IEC 60601-1 Ed 3; ISO 14971; IEC 62366; ISO 62304; ISO 13485 & FDA guidelines CFR 21. Senior Hardware Design Engineer Position Requirements Minimum of more »

accountabilities include, but are not limited to; * Supporting all other departments to ensure they remain compliant to the accreditations strategic to CIL. Primarily; AS9100, ISO 9001, ISO 13485 * Leading product quality in production, which would include containment, investigation, correction, implementation, and validation of corrective actions * Assisting in more »

doing Creating and documenting software for their future product pipeline. Follow all relevant medical device standards in the creation and documentation of software (notably ISO13485, ISO62304 and ISO14971). Write efficient, logical, and well commented and documented code. Perform the verification and validation of the code, including module, sub-system more »

organisation whilst assisting meeting our regulatory responsibilities. Key duties: • Implementation, maintenance, continuous improvement, and support of Blatchford’s Quality Management Systems (in line with ISO13485:2016) and the Medical Device Regulations). • Collaboration across internal departments to provide Quality Assurance support. • Participation in external Quality audit activities. • Representing QA for … qualified or equivalent experience in similar role • Internal audit qualification • Demonstrated experience in a Quality Assurance role, which includes auditing. • Good working knowledge of ISO 13485 (Desirable) • Strong communicator with good interpersonal • Highly analytical • Able to assess information and data leading to rational judgements and successful conclusions. • Ability more »

digital health apps deployed on mobile devices. Familiarity with FDA/MDR/UK MDR medical device software regulation, including relevant standards such as ISO13485, ISO14971, IEC62304, IEC82304, and IEC62366. Deep understanding of the software development lifecycle (SDLC) and best practices in the medical device industry. You will not be more »

digital health apps deployed on mobile devices. Familiarity with FDA/MDR/UK MDR medical device software regulation, including relevant standards such as ISO13485, ISO14971, IEC62304, IEC82304, and IEC62366. Deep understanding of the software development lifecycle (SDLC) and best practices in the medical device industry. You will not be more »

digital health apps deployed on mobile devices. Familiarity with FDA/MDR/UK MDR medical device software regulation, including relevant standards such as ISO13485, ISO14971, IEC62304, IEC82304, and IEC62366. Deep understanding of the software development lifecycle (SDLC) and best practices in the medical device industry. You will not be more »