Location
Acton, Massachusetts, United States
Posted
July 19, 2026
Job Description
Job Summary
Position Overview:The Senior Software Validation Quality Engineer is responsible for leading Design Assurance/Quality activities throughout the IT Systems lifecycles and for automated data processing systems used as part of the quality system. Design Assurance/Quality activities include the review of system Requirements, Specs, Designs, Test Protocols and Reports, Validation Plans and Reports, Trace Matrices, and process validations. This includes ensuring that the IT Software Systems and Tools are compliant with applicable standards, regulations and guidance documents for medical devices and GxP computerized systems. This role will interface with other Insulet departments (e.g.IT, Manufacturing, Management, Operations, Research and Development, and Regulatory Affairs). Interactions are required with vendors and other external parties on issues related to IT Systems, Tools, and Product Development, and software used for automation of the quality system. The abil...