Responsibilities: Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents. Create, review and approve software validation documentation. Create and execute qual...
Responsibilities: We are looking for a product engineer to be brought on for a multi-year project after the acquisition of a new surgical company. Product needs to be fully remediated through review of DHF. Set design inputs and outputs...
Responsibilities: Working knowledge of FDA and European medical device regulations (QSR and ISO) is required. Working knowledge of software validation requirements for software used in the production of medical devices and software used ...