Quality Director - Pre-clinical Class IIb device

A fast-growing, venture-backed pre-clinical Class IIb medical device company is preparing for its pivotal trial, moving from late-stage clinical development toward its first commercial launch. With a strong commitment to 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.

The role is based on site near Atlanta, Georgia, USA.

Essential experience and requirements:

• Early stage, pre-commercial Quality Management experience
• 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