- Develop, implement, and maintain the laboratory s Quality Management System.
- Ensure compliance with regulatory standards (e.g., CLIA, CAP, ISO 15189) and industry best practices.
- Review and update quality policies and procedures regularly.
- Monitor and evaluate the accuracy and precision of laboratory tests and procedures.
- Oversee internal and external quality control programs.
- Ensure proper documentation and reporting of quality control results.
- Prepare for and facilitate internal and external audits and inspections.
- Address and resolve non-conformances identified during audits.
- Implement corrective and preventive actions (CAPA) to address audit findings.
- Provide training and guidance to laboratory staff on quality standards and procedures.
- Develop and maintain training materials and programs related to quality management.
- Ensure staff competency in quality assurance practices.
- Identify areas for process improvement and lead initiatives to enhance laboratory quality and efficiency.
- Analyze quality data to identify trends and implement improvement strategies.
- Foster a culture of continuous quality improvement within the laboratory.
Metrics for the role
Skills we are looking for
- Bachelor s degree in Medical Technology, Clinical Laboratory Science, or a related field. Advanced degree preferred.
- Certification in quality management (e.g., ASQ Certified Manager of Quality/Organizational Excellence) is a plus.
- Minimum of [X] years of experience in a clinical laboratory setting, with at least [Y] years in a quality management role.
- In-depth knowledge of regulatory standards and guidelines (e.g., CLIA, CAP, ISO 15189).
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Proficiency in quality management software and laboratory information systems.
