Quality Engineer 2

Job description

The Quality Engineer II supports product and process quality within regulated environments such as medical device, biotech, or pharmaceutical manufacturing. The role focuses on validating processes, equipment, analytical methods, and facilities to ensure compliance with FDA and ISO regulations. The engineer also supports risk management activities, change controls, regulatory submissions, and cross‑functional product development efforts while maintaining validation documentation and quality systems. Essential Duties and Responsibilities: - Provide quality and validation leadership to new product development teams, including support for design transfer, risk management, and specification development. - Develop and maintain master validation plans, validation protocols, and validation reports. - Execute and document validation activities including analytical method validation, equipment qualification, facility/utility qualification, process validation, cleaning validation, and raw material qualification. - Review document change orders and change control requests for completeness, quality impact, and validation impact. - Determine validation strategies using a risk‑based approach. -...