The Quality Director is responsible for providing regulatory and quality oversight for the Prisma Health System laboratories. The Quality Director works with the quality managers and is available as a resource for quality direction, regulatory interpretation and problem resolution. The Quality Director provides leadership for LabCorp and Health System quality programs including implementation of various quality initiatives.

Requirements:

• Bachelor's degree in Biology, Chemistry, Medical Technology or a related science
• Minimum 5-10 years of clinical laboratory experience
• Previous experience in Quality leadership position within a clinical laboratory required; past CAP inspector experience preferred
• Strong working knowledge of the Quality Assurance function within a laboratory
• ASCP or AMT certification is REQUIRED
• Proficiency with reporting and data analytics
• Strong knowledge of laboratory regulations (CAP/CLIA/ISO) and licensing requirements
• Strong knowledge of regulatory standards - CAP, CLIA, Joint Commission, etc.
• Must be familiar with QC rules and their application within the laboratory
• General understanding of audit related requirements and procedures
• Ability to work independently and within a team environment
• Proficient with computers; familiarity with laboratory information systems required
• Must possess excellent critical thinking and problem solving skills
• Strong communication skills at the executive, peer and subordinate levels; both written and verbal
• High level of attention detail along with strong organizational and prioritization skills
• Proficient in MS Office (Word, Excel, Access, PowerPoint)

The schedule for this position will be: 1st shift, Monday-Friday, 8:00am-5:00pm.

Job Duties/Responsibilities:

• Oversees the Quality Management & Improvement program for a large hospital laboratory system (multiple locations)
• Conduct inspections and works directly with laboratory management team for performance improvement actions
• Oversee the quality and safety committee with varied department representatives
• Monitor metrics in order to support a culture of continuous improvement
• Responsible for providing monthly and quarterly quality metric reports for clients and senior leadership
• Develop and maintain general laboratory policy and procedures (administrative procedure manual, ex. chemical hygiene, infection control)
• Responsible for ensuring audit and inspection readiness with the hospital regulatory team
• Responsible for ensuring reviews of proficiency testing results and ensure appropriate document and corrective actions
• Supports teams to perform internal audits and prepares audit reports
• Responsible for teams who maintain all necessary documents and materials required for inspections
• Assist with responses to regulatory complaints and inspection
• Stay current with all regulatory agency and proficiency test requirements
• Compiles data and dashboards for review during regular Quality meetings
• Lead monthly Quality Meeting and provide updates to leadership as needed
• Coordinate data for quality teams and supports QI efforts
• Perform a variety of administrative tasks as requested by leadership

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