Medical Quality Assessment Manager
Quest Diagnostics
Job Description This position assesses quality activities for all Quest Diagnostics laboratories by, primarily, performing Quality Assessments to ensure compliance with regulatory standards and Quest policies. Responsibilities
- 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"
- 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.
- Supervisory and work experience in clinical Molecular testing. Skills preferred: DNA sequencing, PCR, extraction.
- Hospital work experience
- Experience conducting CAP or other regulatory audits
- 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
- 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
- Bachelor's Degree - Major: Chemical, Biological, or Clinical Laboratory Science or Medical Technology (Required)
- ASCP Specialist Certification (Preferred)
- ASCP Medical Laboratory Scientists (MLS) (Preferred)
- Clinical Laboratory Scientist (CLS) (Required)
- Six Sigma Certified Green Belt (Preferred)
Vacancy posted 2 days ago
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