Manager, CDx Quality Assurance

About this role

About the Job: The Manager, Companion Diagnostic (CDx) Quality Assurance owns end‑to‑end quality for FMI’s CDx development programs for regulated medical devices and IVDs. Partnering closely with Regulatory Affairs, Quality Systems, Complaints, Risk Management, Diagnostic Development and Validation, Clinical Operations, R&D, and Global Lab Operations, this role provides leadership, governance, and operational oversight to ensure CDx programs are executed with patients and users at the forefront, safety, and high quality as the north star. This role is critical to advancing organizational learning, continuous improvement, and sustained patient safety through a mature, scalable CDx product development framework

The Manager leads and develops a team of quality professionals while strengthening investigation rigor and decision‑making across the organization, applying sound judgment in complex, highly regulated environments. Key Responsibilities: Global CDx Quality Assurance lead for Medical Devices and IVDs Lead the global CDx Quality Assurance Medical Device and IVD Development program strategy and execution across FMI, ensuring a risk-based, effective, and inspection-ready approach to CDx product development. Establish clear expectations for CDx Quality Assurance within the product development process throughout the total product lifecycle

Partner with senior Quality leadership to align Medical Device and IVD Product Development governance with broader FMI organization responsible for Product Development, including but not limited to Regulatory Affairs, Clinical Operations, Product, Research and Development, Operations. . Cross Functional Partnership & Risk Management Partner with cross functional stakeholders (Quality, Regulatory Affairs, Diagnostic Development and Validation, Clinical Operations Product, Research and Development, Operations, Laboratory, IT, and Clinical/Lab interfaces) to ensure Medical Device Products and IVD are developed with patient safety fir

Apply for this role on Foundation Medicine’s official careers site.