Phlebotomy Quality Director
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Job Description
Phlebotomy Quality Director ensuring quality standards and regulatory compliance for at-home diagnostics organization. Leading initiatives to enhance patient care and operational efficiency within the mobile phlebotomy sector.
Responsibilities:
- 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
Requirements:
- 3+ years in Quality Assurance or Quality Management, preferably in a mobile phlebotomy or clinical setting
- 5+ years of hands-on phlebotomy experience
- 3+ years of supervisory or people management experience
- Active phlebotomy certification (AMT, ASCP, or NCCT)
- Working knowledge of CLSI standards and CLIA/CAP regulations
Benefits:
- Competitive salary $90K-$100K
- Valuable stock option plan
- Medical, dental and vision insurance options (United States Only)
- Flexible and unlimited vacation
- A company with a huge vision, a dynamic work environment, and a team of talented, ambitious and fun to work-with colleagues!
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