Director, Quality (Clinical Laboratory)

Quest Diagnostics Incorporated
$175000.00-$210000.00
flex time, 401(k)
United States, California, San Juan Capistrano
Sep 07, 2026
Job Description Pay range: $175,000-210,000, plus yearly bonus Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation. Benefits Information We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects - physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include: Day 1 Medical, supplemental health, dental & vision for FT employees who work 30+ hours Best-in-class well-being programs Annual, no-cost health assessment program Blueprint for Wellness healthyMINDS mental health program Vacation and Health/Flex Time 6 Holidays plus 1 "MyDay" off FinFit financial coaching and services 401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service Employee stock purchase plan Life and disability insurance, plus buy-up option Flexible Spending Accounts Annual incentive plans Matching gifts program Education assistance through MyQuest for Education Career advancement opportunities and so much more! The Director, Quality is directly responsible for coordinating and directing all functions of Quality Assurance and theCA CLS Limited License Training Program. This position assumes responsibility for ensuring that all technical and business requirements for laboratory testing are in place and maintained through theQualityManagementSystem. The Director, Quality sitsasamemberoftheBusinessUnit'sLeadershipTeamand is responsible for participating in all associated communications, planning and coordination activities and works closely with Managing Director-Operations/Business/Staffing. Responsibilities: Ensurecompliancewithfederalandstatelawsandregulationsconcerninglaboratorytesting procedures and results. OverseeandmanageoperationsforQualityAssurance,theQualityImprovementSystem, State Licensure, and the CA CLS Limited License Training Program. ManagetheQualityImprovementSystem,whichincludes Root Cause Analysis,CorrectiveandPreventativeAction (CAPA) and Annual Quality Improvement Plans. DirectinternalandexternalauditsrelatedtoISO,CAP,StateLaboratoryAgenciesand Clinical Trials. Ensure quality of new test validations, including Laboratory Developed Tests Responsible for preparedness, the audit process, and follow-up activities. Ensure an effective program of Document Control is in place. Coordinate and approve development of scorecard metrics and goals for Business Unit. Prepare and maintain Management Review document Coordinate corporate quality and Customer directives with local procedures. AssureaccurateandtimelyresponsetoCustomerFeedbackanddemonstratecontinuous improvement to Customer Satisfaction Survey Scores. EnsureTrainingandcompetencyrequirementsaredefinedandachievedattheBusiness Unit. Responsible for Business Unit's compliance with Clinical Trials Service Level Agreement. Identify and relate the quality control, quality management requirements of Quest Diagnostics Inc. and the State, Federal and other agencies to department directors, managers,andsupervisorstoensurethattheserequirementsareimplementedandauditd for compliance. Advise the appropriate supervisor, managers, or technical director, if and when requirements are not met. Inform the Medical Director of such deviations. Advise the Medical Director regarding the quality status of the laboratory on a regularly scheduled basis. Manage off-site and in-house inspections, as required. Assemble and maintain procedures of Quality Assurance Department. Responsible for the selection, retention, training, evaluation and counseling of the Quality Assurance staff. Perform other related duties are requested by the Medical Director, and/or Managing Director. Qualifications: Required Work Experience: 10+ years in a Clinical Laboratory setting. 5+ years of demonstrated leadership and management responsibilities. 3+ years of experience in a Regulatory Environment or demonstrated knowledge in state and federal regulatory requirements. Knowledge: Demonstrated knowledge in state and federal regulatory requirements. Knowledge of ISO15189 standard is desirable. Skills: Demonstrated skills and training in Quality Improvement. Excellent communication skills, verbal and written. Ability to work without direct supervision. Demonstrated ability to collaborate effectively across teams and functions. People Leader Responsibility:Responsible for the selection, retention, training, evaluation and counseling of the Quality Assurance staff. Education Bachelor's Degree (Required) Master's Degree or PhD in Life Sciences or MBA highly desirable. (Preferred) Licenses and Certifications Current California Clinical Laboratory Scientist license. (CA Only-Required) Work Requirements Travel Required 54634 Quest Diagnostics honors our service members and encourages veterans to apply. While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume. Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.