Staff Design Quality Engineer

Position Summary
The Staff Design Quality Engineer is primarily responsible for leading the Design Controls planning, establishing and maintaining the Design history file (DHF), ensuring compliance with all applicable regulations. The position will work in collaboration with the Assay/IVD/CDx Development, Laboratory Operations, Regulatory Affairs, project/program management, and other cross-functional teams throughout the product lifecycle. Requires strong track record of working with the cross functional teams. The role will support management reviews and interna/external audits related to Design Controls and Risk Management.



Job Responsibilities

Responsible for creating the Design and Development Plan (DDP) for the new development projects, updating the DDP throughout the lifecycle of the product.

Create and maintain risk management file with support from cross-functional teams including risk management plan/report, hazard analy...