Senior Staff Deisgn Quality Engineer

Position Summary
Sr. Staff Design Quality Engineer is responsible for leading and managing all quality activities related to design and development, risk management and transfer of design to operations, providing quality oversight, and ensuring compliance with all applicable regulations. The role will be the subject matter expert that leads, influences and make decisions in collaboration with the Assay/IVD/CDx Development, Laboratory Operations, Regulatory Affairs, and other cross-functional teams during development and post market phase.


Job Responsibilities

Lead planning and execution of the new product development and design change projects with focus on Design Controls and Risk Management activities.

Work effectively with cross- functional teams for the harmonization and consistency across several projects.

Take ownership of the processes (Design Controls and Risk Management). Identify improvement opportunities, lead cross...