Quality Manager

Quality ManagerThe 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 FunctionsManages Quality DepartmentCoordinates and maintains all quality assurance program activitiesMaintains systems and controls to ensure consistency and compliance with applicable regulatory requirementsCollaborates with each department on the creation and monitoring of quality indicators for focused process, quality, or performance improvementPlans for improved quality through the use of continuous quality improvement plans (cQIPs), blind audits, and focus studies as neededWorks 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 spreadsheetsMaintains and updates (as needed) the Quality Management System (QMS)Reviews, categorizes, interprets, and identifies trends with internal incident reportsCompiles and completes quarterly quality assessments and annual review of effectivenessHolds quarterly Quality Committee meetings to discuss quality initiatives and performanceParticipates in overall safety compliance initiatives and safety metrics per regulatory requirements; attends monthly Safety Committee meetingsAssumes other duties as assigned by the Laboratory DirectorSupports 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 standardsServes as a resource regarding Clinical Laboratory Improvement Amendments (CLIA) regulations and CAP accreditation standardsInterprets regulations and standards for application in the laboratory and associated sitesCollaborates with department supervisors/managers in ensuring thorough understanding of and compliance with applicable regulations and standardsCoordinates pre-inspection meetings with CAP Team Leads as neededMaintains current state and organizational licensing; coordinates submission of renewal documents as neededSite Administrator for MediaLab software, including Document Control, Compass, and InspectionProofMaintains all controlled documents within MediaLab, assigning new document numbers and creating new manuals as neededEnsures appropriate workflows for document review/approval process within MediaLabCreates and supports the creation of continuing education materials within MediaLabMaintains InspectionProof within MediaLab to ensure the laboratory is inspection-ready at all timesProvides end-user training and/or troubleshooting as neededOther duties as assignedRequirementsProfessional RequirementsUnderstanding of and experience with high-complexity clinical laboratory operationsAnalytical/critical thinking; able to analyze, interpret, and identify trendsDemonstrated success in collaborating and motivating team members to reach objectivesAbility to enact quality improvement through problem solving skills and knowledge of quality toolsAttitude focused on bringing solutionsAbility to properly manage, direct, and supervise a teamProficient with Microsoft Office ApplicationsEducation and Experience RequirementsBachelor's degree (chemistry, physics, biology, clinical laboratory science, or medical technology) requiredMinimum of three years of experience in a laboratory setting requiredPreferred experience: Quality Assurance, Management/Supervision, Statistical Quality Control, Clinical Laboratory Regulations, CAP Accreditation Standards, MediaLab SoftwareKnowledge, Skills and AbilitiesKnowledge of laboratory regulatory requirements, specifically CAP and CLIA; past participation in internal or external laboratory inspection teams preferredAbility to communicate effectively, orally, and in writingChange management, project management, and planning skillsOrganized and able to prioritize and multi-task effectivelyAbility to work independently and function in a team environmentPhysical and Environmental DemandsSome work is performed in a laboratory environment and exposes the incumbent to normal laboratory hazards and chemicals, including biohazard materialsWork 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 seeingDirect ReportsQuality Associate(s), if needed as the department grows