Clinical Laboratory Quality Director
Quest Diagnostics Incorporated
 Marlborough, MA

Job Description

Look for more than answers.

At Quest, we are on a continuous journey of discovery and development. It's this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people.

As a Clinical Laboratory Quality Director, you will work for the world leader in the industry, with a career where you will have the opportunity to collaborate and affect change while expanding your leadership skills and technical knowledge. You can make a real impact in a market that is growing and developing.

Job responsibilities:

  • Regulatory (CMS, NYS, CA)
  • Ensure compliance with federal and state laws and regulations concerning laboratory testing procedures and results.
  • Oversees and manages 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 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. Responsible for preparedness, the audit process, and follow-up activities.
  • Ensure an effective program of Document Control is in place. Business
  • Coordinate and approve development of scorecard metrics and goals for Business Unit.
  • 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 to Clinical Trials Service Level Agreement.
  • Identifies and relates the quality control, quality management requirements of Quest Diagnostics Inc. and the State, Federal and other agencies to department directors, managers, and supervisors to assure that these requirements are implemented and audited for compliance.
  • Advises the appropriate supervisor, managers or technical director, if and when requirements are not met. Informs the Medical Director of such deviations.
  • Advises the Medical Director regarding the quality status of the laboratory on a regularly scheduled basis.
  • Manages off-site and in-house inspections, are required.
  • Assembles and maintains procedures of Quality Assurance Department.
  • Responsible for the selection, retention, training, evaluation and counseling of the Quality Assurance staff.
  • Performs other related duties are requested by the Medical Director, and/or Managing Director.

To qualify, the ideal candidate will have the following skills and 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
  • Bachelor's Degree required. Advanced degree in Life Sciences and Business highly desirable.
  • General California Clinical Laboratory Scientist License or M. D. required.
  • Demonstrated skills and training in Quality Improvement.
  • Excellent communication skills, verbal and written.

Apply Today

Join us for competitive benefits and development opportunities in a progressive and supportive environment. Help us improve our service, and the experiences of our patients and colleagues. Work with us and together we can be better.

Your Quest career. Seek it out.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity.