Quality Manager

JOB OVERVIEW

The Quality Manager reports to the Laboratory Director and coordinates efforts that foster quality and ensure that all pre-analytical, analytical, and post-analytical processes are consistent with applicable state regulations, College of American Pathologist (CAP) standards, and the values and mission of Ethos Laboratories. This person is also responsible for collaborating with each department on quality initiatives and Proficiency Testing (PT) performance, as well as document control, licensing, and accreditation activities. Finally, the Quality Manager completes the day-to-day activities of the quality department and serves as the primary point of contact for regulatory agencies.

ESSENTIAL FUNCTIONS

• Manages Quality Department
• Coordinates and maintains all quality assurance program activities
• Maintains systems and controls to ensure consistency and compliance with applicable regulatory requirements
• Collaborates with each department on the creation and monitoring of quality indicators for focused process, quality, or performance improvement
• Plans for improved quality through the use of continuous quality improvement plans (cQIPs), blind audits, and focus studies as needed
• Works with Laboratory Managers and Laboratory Director to ensure enrollment and participation in proficiency testing (PT) for each analyte, including review/submission of PT results, record keeping, identifying trends, reporting on PT performance in meetings, and maintaining spreadsheets
• Maintains and updates (as needed) the Quality Management System (QMS)
• Reviews, categorizes, interprets, and identifies trends with internal incident reports
• Compiles and completes quarterly quality assessments and annual review of effectiveness
• Holds quarterly Quality Committee meetings to discuss quality initiatives and performance
• Participates in overall safety compliance initiatives and safety metrics per regulatory requirements; attends monthly Safety Committee meetings
• Assumes other duties as assigned by the Laboratory Director
• Supports the internal/external inspection process of the laboratory and associated sites to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation requirements, and Ethos standards
• Serves as a resource regarding Clinical Laboratory Improvement Amendments (CLIA) regulations and CAP accreditation standards
• Interprets regulations and standards for application in the laboratory and associated sites
• Collaborates with department supervisors/managers in ensuring thorough understanding of and compliance with applicable regulations and standards
• Coordinates pre-inspection meetings with CAP Team Leads as needed
• Maintains current state and organizational licensing; coordinates submission of renewal documents as needed
• Site Administrator for MediaLab software, including Document Control, Compass, and InspectionProof
• Maintains all controlled documents within MediaLab, assigning new document numbers and creating new manuals as needed
• Ensures appropriate workflows for document review/approval process within MediaLab
• Creates and supports the creation of continuing education materials within MediaLab
• Maintains InspectionProof within MediaLab to ensure the laboratory is inspection-ready at all times
• Provides end-user training and/or troubleshooting as needed
• Other duties as assigned

PROFESSIONAL REQUIREMENTS

• Understanding of and experience with high-complexity clinical laboratory operations
• Analytical/critical thinking; able to analyze, interpret, and identify trends
• Demonstrated success in collaborating and motivating team members to reach objectives
• Ability to enact quality improvement through problem solving skills and knowledge of quality tools
• Attitude focused on bringing solutions
• Ability to properly manage, direct, and supervise a team
• Proficient with Microsoft Office Applications

EDUCATION AND EXPERIENCE REQUIREMENTS

• Bachelor’s degree (chemistry, physics, biology, clinical laboratory science, or medical technology) required
• Minimum of three years of experience in a laboratory setting required
• Preferred experience: Quality Assurance, Management/Supervision, Statistical Quality Control, Clinical Laboratory Regulations, CAP Accreditation Standards, MediaLab Software

KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of laboratory regulatory requirements, specifically CAP and CLIA; past participation in internal or external laboratory inspection teams preferred
• Ability to communicate effectively, orally, and in writing
• Change management, project management, and planning skills
• Organized and able to prioritize and multi-task effectively
• Ability to work independently and function in a team environment

PHYSICAL AND ENVIRONMENTAL DEMANDS

• Some work is performed in a laboratory environment and exposes the incumbent to normal laboratory hazards and chemicals, including biohazard materials
• Work in varying degrees of temperature (heated or air conditioned)
• Position requires sitting, walking, reaching, bending, stooping, and handling objects with hands and/or fingers, talking and/or hearing, and seeing

DIRECT REPORTS

• Quality Associate(s), if needed as the department grows