Description
The Quality Systems Engineer will plan, execute, and document validation of regulated non-product software systems used in product development, manufacturing, and business operations. The role collaborates with developers, vendors, QA, regulatory affairs, and system users to define validation requirements and acceptance criteria, analyze requirements for testability and compliance, and apply standards such as FDA 21 CFR Part 11, ISO 13485, and related regulations. The position requires a relevant engineering or science degree, at least three years of medical device experience in a quality or regulatory role, and hybrid onsite work.
