Job Description
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
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
💡 Quick Summary
Seeking a career-building opportunity? The Quality Director - Pre-clinical Class IIb device position is now open for candidates interested in the Health Jobs sector. This role in Atlanta offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Health Jobs is a plus.
