• Develop, administer, and continuously improve quality programs, processes, and SOPs aligned with regulatory standards and partner requirements (CLSI, CLIA, CAP) • Lead root cause investigations for all phlebotomy errors, manage the corrective action process, and ensure effectiveness checks are completed within 48 business hours • Manage internal and external audits, address findings, and formulate partner-facing responses to complaints, nonconforming events, and regulatory citations, and maintain regulatory compliance • Identify high-risk draws and flag potential issues during onboarding to prevent errors • Maintain monthly Quality Specialist scorecards, review KPIs, and support development planning • Analyze clinical data, monitor key performance indicators (KPIs), report on trends, and use insights to enhance patient care and operational efficiency • Provide strategic direction for quality initiatives to cross-functional teams, collaborate with senior leaders, executives and field operations • Lead quality initiatives to achieve performance goals; Implement continuous improvement methodologies, refine standard operating procedures (SOPs), and optimize processes for safety, effectiveness, and efficiency • Risk Management: Identify, assess, and mitigate clinical risks, ensuring new partner launch and trial readiness, and maintaining high standards for patient care