Quality Director - QMS Compliance

A fast-growing, venture-backed medical device company is entering a pivotal phase, moving from late-stage clinical development toward first commercial launch. With a strong commitment patient safety, the company is building technology designed to change clinical practice while scaling toward a multi-product future.

This role is created to own and elevate the Quality Management System as the organisation prepares for market entry. Reporting directly to the CEO, you will play a central, hands‑on role in strengthening QMS compliance, ensuring audit readiness, and building a scalable quality foundation that supports both current and next‑generation products.

This is a true “doer” role with high visibility, autonomy, and long‑term growth potential as the company expands.

Please note the role requires presence at the office in Roswell, Georgia, USA.

• Hands‑on medical device quality experience (ISO 13485 / FDA QSR)
• Direct ownership or strong involvement in QMS implementation or maintenance
• Practical experience with SOPs, CAPA, document control, and audit readiness
• Background in Class II / IIb devices (Class III exposure a plus)
• Comfortable working autonomously in a scaling, pre‑commercial environment
• Willingness to be primarily office‑based for close collaboration and oversight