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 WorkExperience:

• 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

• Bachelors 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)