SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES: • Manage QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to FDA, ISO, MDD/MDR, and individual country requirements). • Manage Document Control system, including the Change Order process. • Manage the CAPA, Complaints, SCAR, and Audit Findings processes. • Lead supplier management, including maintaining the Approved Supplier List for Critical/Crucial Suppliers and facilitating the re-evaluation of suppliers, including review of supplier data as appropriate. • Own the development of Quality Metrics, and coordinate quality data collection and analyses for use in Management Reviews. • Lead for regulatory body audits. • Manage the Internal and Supplier Audit processes. • Lead Management Review and Quality Planning. • Lead and manage site training program. • Track and report on company Quality KPIs. • Organize and lead monthly company meetings on established KPIs and Trends. • Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS. • ISO 13485 and FDA Quality System Regulation • Certified Internal Auditor preferred • Lean and Six Sigma Green Belt Certified preferred