Director, Quality (Clinical Laboratory)

Quest Diagnostics Incorporated; San Juan Capistrano (CA); On-site; USD 175,000 - 210,000; Full time

Benefits offered by this job

Day 1 Medical, dental & vision

401(k) with company match

Education assistance

Job summary

Quest Diagnostics Incorporated is seeking a Quality Assurance Manager in San Juan Capistrano, California. This position oversees compliance with laws concerning laboratory testing and manages the quality assurance operations.

The ideal candidate will have over 10 years in a clinical lab setting and experience in regulatory environments. Responsibilities include overseeing audits and ensuring the quality of new test validations. Excellent communication skills are essential.

Qualifications

• 10+ years in a Clinical Laboratory setting.
• 5+ years of demonstrated leadership and management responsibilities.
• 3+ years of experience in a Regulatory Environment.

Responsibilities

• Ensure compliance with federal and state laws concerning laboratory testing.
• Oversee operations for Quality Assurance and Quality Improvement System.
• Manage internal and external audits related to ISO and CAP.
• Ensure quality of new test validations.

Skills

Quality Improvement

Communication Skills

Collaboration

Regulatory Knowledge

Education

Bachelor's Degree

Master's Degree in Life Sciences and Business

Job description

Pay Range

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

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!

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, which includes 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 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.
• Assure 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 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, and supervisors to ensure that these requirements are implemented and audit 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 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 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

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.