Medical Quality Assessment Manager

This position assesses quality activities for all Quest Diagnostics laboratories by, primarily, performing Quality Assessments to ensure compliance with regulatory standards and Quest policies.

• Conduct and/or lead internal inspections of Quest Diagnostics domestic and international laboratories. This includes the following: Esoteric laboratories, Regional laboratories, AmeriPath Diagnostics, Quest hospital laboratories (QHLs), rapid response laboratories, joint venture laboratories, point of care testing and contracted laboratories. 
• Compose and submit timely and accurate inspection reports for corresponding inspections.
• Manage inspection responses to ensure completeness and accuracy.
• Maintain knowledge of laboratory regulatory requirements, to include accrediting bodies, federal, state, and local requirements as well as Quest Diagnostics policies.
• Represent MQA on various company teams/groups related to laboratory testing.
• Provide communication to the laboratories on relevant quality issues.
• Collaborate with National Laboratory Operations and Business Transformation teams.
• Serve as a resource and subject matter expert (SME) to laboratories for quality and regulatory issues.
• Participate in quality monitoring activities for Clinical Pathology, as required (e.g., metrics, Proficiency Testing (PT), CAP educational surveys, CAP, RQI, etc.).
• Prepare written communications and deliver presentations to laboratories, as required.
• Provide on-site consultation on quality and/or regulatory issues.
• Support and participate in special company-wide projects etc.
• Participate in annual continuing education and company training, as designated.
• Comply with all Quest Diagnostics policies including, but not limited to:
  • Employee Handbook
  • “Your Compliance Policy Handbook”

Required Work Experience: 

• Three (3) years-experience in a laboratory, including leadership responsibilities – required
• Three (3) years-experience in laboratory quality assurance/quality control activities, including laboratory regulations/accreditation requirements – required
• Experience managing a laboratory department, to include pre-analytic, analytic and post analytic QA/QC activities.
• Graduate of NCCLS approved program or equivalent education.

Preferred Work Experience: 

• Supervisory and work experience in clinical Molecular testing. Skills preferred: DNA sequencing, PCR, extraction.
• Hospital work experience 
• Experience conducting CAP or other regulatory audits 

Physical and Mental Requirements: 

• Maintain composure under pressure
• Adapts to change
• Ability to grasp information quickly
• Ability to multi-task
• Using effective verbal communication
• Using effective written communication 
• Handle stress & emotions
• Making decisions
• Examine/observe details

Skills: 

• Proficient in Microsoft Word, Excel, Outlook, PowerPoint etc.
• Possesses excellent communication (verbal and written), influencing, and collaboration skills
• Ability to work independently and effectively plan/organize work and projects
• Demonstrate team building and problem-solving skills

Education

• Bachelor’s Degree - Major: Chemical, Biological, or Clinical Laboratory Science or Medical Technology (Required)

Licenses and Certifications

• ASCP Specialist Certification (Preferred)
• ASCP Medical Laboratory Scientists (MLS) (Preferred)
• Clinical Laboratory Scientist (CLS) (Required)
• Six Sigma Certified Green Belt (Preferred)