Job Title: VP Quality
Location: Georgia, US
Job Type: Full Time, Permanent
A rapidly growing, publicly traded medical device organization headquartered in the Greater Atlanta area is seeking an experienced Vice President of Quality to lead all aspects of its quality systems, compliance, and operational excellence. The company develops and manufactures innovative, minimally invasive medical technologies focused on improving outcomes in women’s health. With multiple patented platforms in development and commercialization, the organization is entering a critical phase of scaling operations, global regulatory expansion, and market launch.
This confidential search represents a key leadership opportunity to shape the quality strategy and infrastructure for a company poised for significant growth in the medical device industry.
The Vice President of Quality will serve as the senior executive responsible for establishing and maintaining the company’s Quality Management System (QMS), ensuring compliance with global medical device regulations, and driving a culture of quality across all business functions.
This leader will oversee quality assurance, quality control, compliance, and supplier quality functions, and will work cross-functionally with R&D, operations, manufacturing, regulatory affairs, and executive leadership to ensure the highest standards of product quality, reliability, and patient safety.
Key Responsibilities
- Develop, implement, and maintain a global Quality Management System compliant with ISO 13485, 21 CFR 820, and EU MDR requirements.
- Serve as a strategic advisor to executive leadership on all quality and compliance matters.
- Lead organizational initiatives to embed quality into every phase of product development, manufacturing, and commercialization.
- Act as the primary liaison for regulatory inspections and audits (FDA, ISO, notified bodies, and international agencies).
- Oversee internal and supplier audit programs, CAPA systems, and risk management processes.
- Ensure robust design control, process validation, complaint handling, and change control systems.
- Lead quality support for internal manufacturing operations and contract manufacturing partners.
- Establish and manage supplier qualification and monitoring programs.
- Ensure quality standards are consistently met throughout the product lifecycle—from incoming materials to finished goods release.
- Drive a culture of continuous improvement and operational excellence.
- Lead major investigations, root-cause analyses, and preventive/corrective actions.
- Develop key quality metrics, dashboards, and executive reports to monitor organizational performance.
- Build and lead a high-performing, cross-functional quality organization.
- Mentor and develop team members to ensure strong technical and leadership capabilities.
- Represent the quality function in executive meetings and strategic planning discussions.
Requirements:
- Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline (advanced degree preferred).
- 12 + years of progressive quality leadership experience in the medical device or diagnostics industry.
- Proven success managing quality systems compliant with FDA QSR, ISO 13485, and EU MDR.
- Experience with both early-stage and commercial medical device environments preferred.
- Demonstrated track record leading through regulatory audits and scaling quality operations.
- Deep knowledge of global medical device quality and regulatory frameworks.
- Strong leadership, communication, and change-management skills.
- Ability to balance regulatory compliance with business agility and innovation.
- Collaborative and decisive leader capable of influencing at all levels.
- Strategic mindset with hands-on operational execution capabilities.
