Quest Diagnostics · 4 months ago
Manager, Quality Assurance
San Antonio, TX
Full-time
Onsite
Senior Level
6+ years expQuest Diagnostics is a leading provider of diagnostic information services, and they are seeking a Manager of Quality Assurance to oversee and coordinate quality efforts across various processes. The role involves ensuring compliance with regulatory standards, leading quality improvement initiatives, and managing public health reporting functions.
BiotechnologyHealth CareHealth DiagnosticsInformation ServicesPrecision Medicine
Responsibilities
Direct, advocate for and enable visibility of quality processes
Ensure accountability within all areas of the business unit (pre-analytical, analytical and post-analytical) such that every employee consistently exhibits behavior that promotes and supports quality
Influence may be exerted both directly and indirectly through the management of liaisons and intermediaries, such as department managers and supervisors as well as the Quality Assurance (QA) and Public Health Reporting staff
Direct internal inspection process of the business unit, associated laboratories and specimen collection sites to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation requirements and Quest Diagnostics standards. Review and ensure that corrective action is implemented when non-conformances are found
Monitor published guidelines for revisions to regulations and/or accreditation standards and ensure laboratory compliance. Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations and CAP accreditation standards for all sites
Ensure all testing facilities/personnel have appropriate licensure and accreditation as deemed by federal, state, and local regulations. Collaborate with business unit management even if primary responsibility has not been assigned to QA
Identify all tests performed and ensure enrollment and participation in external proficiency testing for each test. For those tests not covered by external proficiency testing, ensure internal proficiency testing is performed. Ensure that all proficiency testing is reviewed, and corrective action is complete for all non-conformances
Ensure that the Public Health System is in compliance with Public Health Reporting Laws of all the states within the region
Manages the Public Health functions of the staff
Ensure that a defined instrument-to-instrument, method-to-method, and laboratory-to-laboratory comparison process, with fixed criteria for accessing acceptability, is performed and documented at least semi-annually
Conduct monthly QA meetings with required participation by all areas (including RRLs) having an impact on pre-analytical, analytical and post-analytical phases of testing (exception Billing)
Ensure that each department has a comprehensive Quality Management System plan with monitors and that each department communicates their metrics and implements appropriate actions
Develop, monitor and improve Quality Assurance specific quality indicators, including but not limited to: Reportable Quality Issues, Proficiency Testing outcomes, Revised Reports tracking, and performance on inspections
Ensure all applicable employees are trained and comply with local quality policies. Ensure all QA policies have a biennial review
Ensure a process is in place to resolve customer complaints regarding pre-analytical, analytical, and post-analytical issues
Ensure performance of required Corporate Quality Inspection Program, Patient Results Distribution Program, Life Cycle Management Team Initiative/Database Changes Verification Program and other monitoring programs specifically assigned by Medical Operations and Quality (MOQ)
Ensure enrollment and participation in external federal and state cytology proficiency testing as well as required educational programs
Act as a contact for national Quality Control (QC) peer comparison programs and ensure enrollment and effective corrective action as appropriate
Ensure all duties are appropriately delegated as required by applicable federal, state and local regulations
Ensure that all departments have a process to identify and evaluate the relationship of patient information to patient test results. Ensure the process is in place, up to date, distributed and that all personnel are in compliance
Ensure prompt and complete reporting Reportable Quality Issues in compliance with the Standard Operating Procedure (SOP) and ensure effective corrective action including issuance of revised reports as applicable
Ensure complete tracking of revised reports in compliance with the SOP and ensure effective corrective action
Ensure compliance with all Quest standards as required
Qualification
Required
Bachelor of Science in Medical Technology, Biology or Chemistry
Certifications and qualifications, as General Laboratory Supervisor, as defined by CLIA '88 are required
Foreign educated candidates must provide a detailed credential evaluation from IERF (International Education Research Foundation)
United States educated candidates must provide a detailed original transcript
Minimum of six years clinical experience with two years participating in Quality Assurance initiatives or QA leadership roles
Must demonstrate effective communication and collaboration skills within department as well as with other functions within the company and third parties (ie., clients)
Must have the ability to establish work priorities for self and others and handle several procedures simultaneously
Must protect patient confidentiality at all times
Preferred
Masters in Biological Science, or equivalent, is preferred
Direct or Indirect people leader experience is preferred
Demonstrated success in motivating team members to reach objectives is highly desirable
Company
Quest Diagnostics
Quest Diagnostics is a clinical laboratory that offers diagnostic testing, services, and information.
10001+ employees
H1B Sponsorship
Quest Diagnostics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (59)
2024 (38)
2023 (74)
2022 (56)
2021 (49)
2020 (45)
Funding
Current Stage
Public CompanyTotal Funding
$2.6B2024-08-15Post Ipo Debt· $1.85B
2023-10-30Post Ipo Debt· $750M
1996-12-17IPO
Leadership Team
James Davis
Chief Executive Officer and President
Cecilia McKenney
SVP & Chief Human Resources Officer
Recent News
2026-01-09
Company data provided by crunchbase