Serve as a key quality leader responsible for designing, deploying, and sustaining a robust, compliant, and scalable Quality Management System (QMS) across the World‑Wide Advanced Diagnostics (ADx) division.
Drive standardized and unified quality processes globally, ensuring compliance with FDA QSR, ISO 13485, MDSAP, MDR/IVDR, Japanese PAL, and other applicable global standards.
Act as a strategic partner to senior leadership, ensuring quality systems support patient safety, regulatory compliance, and operational excellence across clinical and industrial IVD and medical device applications.
Operate with a high level of autonomy, exercising independent judgment to solve complex quality system challenges while aligning resources, budgets, and schedules with ADx strategic goals.
Report directly to the Sr. Director, Quality Systems, supporting the ongoing development, implementation, and continu...