QA Engineer - 778

QA Engineer Our SME quality assurance group is looking for a new member! This is your opportunity to take part and make a real impact, supporting the development processes of cutting-edge medical devices. Description SME (Special Matter Expert) Quality group at a medical device company is looking for a Quality Leader who will be a content expert for quality issues required in the development and production stages of medical products. The role includes supporting the initial development stages (C&F), advanced development stages (Design Validation and Verification), transferring the product from development to production up to its ongoing production while meeting international regulatory requirements. Responsibilities : Leading the quality issues in the area of Development Life Cycle and manufacturing, including providing quality and regulatory emphasis in the Risk Management process Accompanying the teams in defining the testing arrangements for the product (Design Verification and Validation) and various validation processes (equipment, method, sterilization and cleaning validation). Support in leading process improvements and managing the implementation of changes throughout the development stages of the product and its transfer to production. Writing quality documents Approval of development and production documents Requirements B.Sc., in the field of science - mandatory Previous significant experience in quality assurance roles in R&D environment – mandatory Experience in a company manufacturing medical devices / pharma – mandatory Experience in validation processes (equipment and process). Knowledge in software validation processes - advantage Knowledge in design validation and post marketing surveillance - advantage Mastering International Standards, ISO 13485, FDA Guidelines, MDR English – high level Ability to drive processes and orientation towards results