Director, Quality
Quest Diagnostics Incorporated
San Juan Capistrano, CA (In Person)
$192,500 Salary, Full-Time
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Job Description
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 ofISO15189
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 Advanced degree in Life Sciences and Business 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.Similar remote jobs
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