Laboratory Quality and Compliance Manager

Job Summary

The Manager Laboratory Quality and Point of care is responsible for quality, compliance, and process improvement activities of the clinical laboratory areas. This position coordinates accreditation activities for laboratory services across the organization (Laboratory and Point of Care).

Job Responsibilities

• Oversee quality control program and quality assurance program to ensure high quality diagnostic testing and all laboratory activities follow organization and regulatory agency standards.
• Responsible for the quality activities of the clinical laboratory areas and coordination of accreditation activities for the laboratories at Riverview Health.
• Oversee point of care sites across the organization and coordinate accreditation activities for testing performed outside the laboratory.
• Develop and implement general lab policies and procedures and actively participate in the review of new and revised policies and procedures.
• Develop audit tools and mechanisms for evaluation of workflow and productivity for efficiency and use quality metrics to improve laboratory services.
• Ensure enrollment in proficiency testing across the organization commensurate with activities performed in each laboratory. (CLIA waived, CLIA non-waived, PPT)
• Work with vendors and evaluate products to provide quality technical services.
• Provide input to the budget process and proactively contribute to meeting the revenue and expense targets of the fiscal year department budget. May use technical consultants as needed to estimate cost of capital or other expenses.
• Interview, hire, onboard, and manage the performance of direct reports. Effectively work with other Laboratory leaders, Human Resources, and other support areas as needed to establish departmental practices that maximize retention and drive performance to meet department and organizational goals.
• Provide consistent, objective, and regular feedback to direct reports to ensure understanding and accountability and growth.
• Participate in the development of effective teams across laboratory disciplines and motivate staff to work together toward common goals. Provide functional and professional growth opportunities through the identification and delivery of educational resources and training.
• Work with Laboratory leadership and other teams across the organization to ensure quality, accreditation and compliance goals are met. Collaborate on improvement initiatives to ensure alignment with customer needs and the delivery of effective lab services.
• Other duties as assigned.

Education Requirements

• Minimum: Bachelor’s degree in medical technology, or chemical, physical, or biological science from an accredited institution and have at least five years of laboratory training or experience, or both, in high complexity testing within the specialty with a minimum of six months experience in high complexity testing within the subspecialty. 
• Preferred: Master’s degree in clinical laboratory science, Medical Technology, or Business Administration and ten years of laboratory training or experience, or both, in high complexity testing within the specialty with a minimum of six months experience in high complexity testing within the subspecialty. 

Experience Requirements

• Minimum: Five (5) years of experience in hospital laboratory setting. Laboratory testing (general lab), quality reporting, laboratory accreditation, phlebotomy, point of care, and management. Prior experience working in a position of oversight of an analytical or quality function of the laboratory with a strong understanding of regulation and compliance is required.
• Preferred: Minimum plus three (3) years Quality Assurance/QC experience in hospital laboratory setting. Laboratory testing (general), quality reporting, laboratory accreditation, LIS administration and laboratory management, point of care testing and management, technical supervision of lab, Lean Six Sigma process improvement and implementation.

License/Certification Requirements

• Minimum: MT (ASCP) registered or MLS certified. Must meet requirements for Technical Supervisor and Technical Consultant under CLIA 1988.