Job Details

Process Development & Standardization: Design and refine the quality processes that support our combination product development lifecycle, with a focus on developing and implementing standardized work and best practices to be applied consistently across all MDCP programs. Champion initiatives to improve the systems governing design controls, change control, and documentation. Interface & Boundary Definition: Architect the operational interfaces and delineate clear system boundaries between key internal partner functions (e.g., Drug Product, Packaging, Device Engineering, etc). Establish formal processes for hand-offs and define ownership to ensure seamless integration in the development cycle. Project Leadership & Execution: Serve as the lead Quality Engineer on critical development projects, providing hands-on guidance to teams for design verification, validation, and design transfer activities. You will be the central quality expert ensuring project milestones are met in a compliant ...Quality Assurance, Director, Quality, Assurance, Product Development, Project Management, Technology