Sr. Manager, Quality Design Assurance

About this role

About the Job: The Sr Mgr, Quality Design Assurance owns end‑to‑end quality for FMI’s regulated medical devices and IVD development processes. Partnering closely with Product Development, Regulatory Affairs, Quality Systems, Complaints, Risk Management, R&D, and Global Lab Operations, this role provides strategic leadership, governance, and operational oversight to ensure products are designed and developed with patients and users at the center, safe, high quality, and inspection ready. This role is critical in advancing organizational learning, continuous improvement, and sustained patient safety through a mature, scalable product development framework

The Senior Manager leads and develops a high performing 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 Design Assurance lead for Product Development of Medical Devices and IVDs Program Leadership Lead the global Medical Device and IVD Design Assurance program strategy and execution across FMI, ensuring a risk-based, effective, and inspection-ready approach to product development. Establish clear expectations for design 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, Product, Research and Development, Operations, Laboratory, IT, and Clinical/Lab interfaces) to ensure Medical Device Products and IVD are developed with patient safety first and right the first time mentality

Serve as a subject matter expert on product

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