Manager, Quality Assurance

Provides management for designated hospital laboratory.  Develops/monitors orientation and training programs for supervised personnel.  Evaluates and counsels supervised personnel.  Develops, implements, and maintains quality assurance policies and procedures to meet regulatory requirements and industry standards. Ensures compliance with relevant regulatory bodies (e.g., CLIA, CAP, ISO) by staying abreast of regulatory updates, conducting audits, and implementing corrective actions as necessary. Oversees the creation, maintenance, and review of documentation related to quality management, including SOPs, quality control records, and proficiency testing results.  Monitors/audits quality control processes to ensure the accuracy and reliability of laboratory test results. This includes, reviewing proficiency testing results and deviations. Provides training and education to laboratory staff on quality management principles, regulatory requirements, and best practices for quality assurance. Identifies potential risks to quality and develop strategies to mitigate these risks. Conducts risk assessments and implement preventive measures to maintain quality standards.  Leads initiatives to improve laboratory processes, enhance efficiency, and optimize resource utilization.  Analizes quality metrics and implement corrective actions to address areas for improvement.  Serves as a liaison with regulatory agencies, accreditation bodies, and external auditors.  Coordinates inspections and audits, and facilitate responses to findings and recommendations. Communicates quality-related information effectively to laboratory staff, management, and external stakeholders.  Fosters a culture of quality and accountability within the laboratory.  Monitors key performance indicators related to quality management and report findings to senior management.  Implements measures to track and evaluate the effectiveness of quality assurance activities.