Job Summary :

The Senior Quality Assurance Engineer (Design Assurance) is responsible for providing oversight and governance of Design History Files (DHF) to ensure compliance with regulatory standards and internal quality role plays a key part in guiding design controls, facilitating design transfer, and managing risk documentation across medical device product lines (Class I and Class II (k)). The engineer will ensure that all processes and documentation meet FDA and ISO standards, and that design changes are properly controlled and documented.

Roles & Responsibilities :