2 ISO 13485 Jobs in Suffolk

will be provided to assist carrying out these responsibilities. Main duties will include ? Generating usability documentation for regulatory submission of the product range with ISO practices. ? Leading , running and moderating use studies ? Working closely with the project and wider teams to create a device that meets the customers needs. … travel may be required Candidate Attributes ? Minimum of 2 years experience and relevant qualifications in usability and human factor engineering ? Practical experience ? Knowledge of ISO 13485 Practices. ? Experience in planning and conducting user studies ? Knowledge of use risk management processes ? Documentation writing skills and ability MS office programs … further information or call (01842) 820409 Skills Required Engineer, communication skills, ISO 13485, Risk management, Travelling, Organise meetings, Medical components, Qualifications Required ISO13485, Human factor, Usability, IEC62366 Keywords Engineer, communication skills, ISO 13485, Risk management, Travelling, Organise meetings, Medical Components/ more »

concepts to diverse audiences. Strong knowledge of regulatory requirements and quality standards applicable to medical device development and manufacturing, such as FDA regulations and ISO 13485. Our Benefits: 26 days' holiday with the option to buy or sell an additional 5 Up to 10% employer pension contribution Share and more »