As a member of a cross-functional team, the Sr. Quality Engineer, Design Assurance is responsible for quality throughout new product development and improvement up to and including technology transfer and commercialization. The Sr. Quality Engineer, Design Assurance ensures that applicable elements of the Quality System and external standards are followed. As the voice of Quality, the Sr. Quality Engineer, Design Assurance applies best-practice quality, team-based and statistical tools and techniques, and promotes the value and use of such tools throughout the organization.

Principal Responsibilities

• Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design such as design verification, design validation, design reviews, design transfer, and all other aspects of a design history file.
• Create and maintain risk files consisting of but not limited to risk management pl...