Manager, CDx Quality Assurance

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 Responsibili...