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Clinical Laboratory Quality Assurance Director

2 months ago

Jupiter, Florida, United States Access Medical Laboratories Full time
Job Title: Clinical Laboratory Quality Assurance Manager

About the Role:

Access Medical Laboratories is seeking a highly skilled and experienced Clinical Laboratory Quality Assurance Manager to join our team. As a key member of our laboratory team, you will be responsible for ensuring the highest quality standards in our clinical laboratory operations.

Key Responsibilities:

  • Quality Management: Develop, implement, and maintain our laboratory's quality management system, ensuring compliance with regulatory requirements, industry standards, and best practices.
  • Regulatory Compliance: Ensure that all laboratory processes and procedures meet or exceed regulatory requirements, including CLIA, CAP, and ISO standards.
  • Quality Improvement: Lead quality improvement initiatives, manage audits and inspections, and foster a culture of continuous improvement and compliance within the laboratory.
  • Leadership and Collaboration: Collaborate with laboratory staff and other stakeholders to identify opportunities for improvement and implement best practices.
  • Training and Development: Develop and deliver training programs to laboratory staff on quality management principles, regulatory requirements, and best practices.
  • Risk Management: Identify potential risks to the quality and reliability of laboratory services and implement strategies to mitigate these risks.
  • Reporting and Communication: Prepare and present quality reports to senior management and regulatory authorities as required.

Requirements:

  • Bachelor's degree in Medical Technology, Clinical Laboratory Science, or a related field.
  • 5+ years of QA lab experience in the laboratory setting required.
  • Registered Medical Technologist, ASCP, AMT or NCA and must qualify as Testing Personnel under CLIA guidelines.
  • Valid Florida Clinical Laboratory Supervisor's license required.
  • Certification in Quality Management (e.g., ASQ CQE, CQA) or related certification is highly desirable.
  • In-depth knowledge of laboratory regulatory requirements and standards (e.g., CLIA, CAP, ISO).
  • Strong understanding of quality management principles, methodologies, and tools.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Demonstrated leadership and organization skills.
  • Excellent oral and technical writing skills with the ability to interface effectively and professionally at all levels.