3 IEC 62304 Jobs in the South East

Contract Automated Tester - TypeScript/React (Medical Devices) ISO13458 IEC 62304 UK Remote Role Our client is a leading player in the medical device industry, dedicated to developing innovative solutions that enhance patient care and healthcare efficiency. They are currently seeking a Contract Automated Tester specializing in TypeScript … to integrate automated testing into the CI/CD pipeline. - Conduct comprehensive testing of medical device software functionalities to ensure compliance with ISO13458 and IEC 62304 standards. - Identify and report software defects, working closely with developers to resolve issues. - Maintain and update automated test suites to reflect changes … an Automated Tester. - Strong proficiency in test automation frameworks such as Cypress, Cucumber, and playwright or any other automation tools - Familiarity with ISO13458 and IEC 62304 standards for medical device software development. - Excellent problem-solving skills and attention to detail. - Effective communication and collaboration skills, with the ability more »

. Familiarity with FDA/MDR/UK MDR medical device software regulation is essential including applicable standards such as ISO 13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366. Deep understanding of software development lifecycle (SDLC) and best practices in the medical device Industry. more »

with implementing and maintaining Quality Management Systems (QMS) in accordance with ISO standards. · Knowledge of ISO Standards including ISO 13485, ISO 9001, ISO 14971, IEC 62304 and EN 60601. · Knowledge of global regulatory requirements applicable to the company's products and services, such as (EU) 2017/ more »