Seeking a proactive, hands-on Quality Manager to build, lead, and continuously improve our Quality Management System (QMS). This role is ideal for a quality professional who thrives in a fast-paced, early-stage environment and wants to directly influence product development, regulatory readiness, and company culture. Responsible for maintaining compliance with FDA 21 CFR Part 820 and ISO 14971, while also supporting design control, supplier qualification, risk management, and post-market processes.