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Job description
Job Description
Pay range: $175,000-210,000, plus yearly bonus.
Salary offers are based on relevant skills, training, experience, education, and certifications, as well as market and organizational factors. Successful candidates may be eligible for an annual performance bonus.
Benefits
Day 1 Medical, supplemental health, dental & vision for full‑time 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
Director, Quality is directly responsible for coordinating and directing all functions of Quality Assurance and the CA CLS Limited License Training Program. The role ensures that all technical and business requirements for laboratory testing are in place and maintained through the Quality Management System. The Director sits as a member of the Business Unit's Leadership Team, participates in all associated communications, planning and coordination activities, and works closely with the Managing Director‑Operations/Business/Staffing.
Location: Quest’s San Juan Capistrano, CA site. Hybrid schedule: 3 days in office.
Responsibilities
Ensure compliance with federal and state laws and regulations concerning laboratory testing procedures and results.
Oversee and manage operations for Quality Assurance, the Quality Improvement System, State Licensure, and the CA CLS Limited License Training Program.
Manage the Quality Improvement System, including Root Cause Analysis, Corrective and Preventative Action (CAPA) and Annual Quality Improvement Plans.
Direct internal and external audits related to ISO, CAP, State Laboratory Agencies and 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 Document Control program is in place.
Coordinate and approve development of scorecard metrics and goals for the Business Unit.
Prepare and maintain Management Review documentation.
Coordinate corporate quality and Customer directives with local procedures.
Ensure accurate and timely response to Customer Feedback and demonstrate continuous improvement to Customer Satisfaction Survey Scores.
Ensure training and competency requirements are defined and achieved at the Business Unit.
Responsible for the Business Unit's compliance with the Clinical Trials Service Level Agreement.
Identify and communicate quality control and quality‑management requirements of Quest Diagnostics Inc. and external agencies to department directors, managers, and supervisors to ensure implementation and audit readiness.
Advise appropriate supervisors, managers, or technical directors 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 the Quality Assurance Department.
Responsible for selection, retention, training, evaluation, and counseling of the Quality Assurance staff.
Perform other related duties as requested by the Medical Director 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 of state and federal regulatory requirements.
Knowledge
Demonstrated knowledge of 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 Advanced degree in Life Sciences and Business highly desirable (Preferred).
Licenses and Certifications
Current California Clinical Laboratory Scientist license (Required).
Work Requirements
Travel Required.
Equal Opportunity Employer
Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.
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Worksite address
san juan capistrano, CA, 92675, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.