Quality Systems Director

Organization
GeneDx, Inc.
Job Location
Gaithersburg, MD
Benefits

As a GeneDx employee you will become part of a company that has received national recognition and is a great place to work. We offer excellent full-time benefits to include 17 days paid time off per year, participation in the company's group health insurance, life, disability, 401K retirement plans

Job Description

Quality Systems Director

GeneDx, Inc

Gaithersburg, MD

 

GeneDx is rapidly growing CLIA-Certified diagnostic genetics laboratory. We provide cutting edge technologies for genetic molecular diagnostics and offer vital, new-platform products in the critical area of molecular diagnostics. We specialize in genetic testing for rare hereditary disorders, but also test for common disorders.  Our primary mission is to make clinical testing available to people with rare genetic conditions and their families.  Because of our tremendous growth, we are in search a full time Quality Systems Director.

GeneDx is recruiting for a Quality Systems Director who will be responsible for planning, coordinating and overseeing all of the functions within the scope of Quality Systems, including the Quality Control Program, Quality audits, standard operating procedures, regulatory standards, and obtaining and maintaining all accreditations to ensure that services are of the highest quality.

 

Responsibilities:

  • Develop, implement, communicate, and maintain quality control (QC) and quality monitoring programs according to standards of ACMG and CAP.
  • Define and maintain QC/QMP objectives, targets, processes and review new targets, plans, and protocols for maintenance of the QCP as needed.
  • Establish and maintain QC/QMP documentation procedures as needed.
  • Maintain, develop, and coordinate document control processes.
  • Perform regular internal quality audits in all laboratories; follow up with recommendations, corrective, and preventive actions as needed.
  • Assure proper qualification of laboratory personnel according to CLIA, CAP, and NYS standards.
  • Assure proper maintenance and calibration of laboratory equipment.
  • Assist in the maintenance of accreditation, permits and licenses in regard to inspections and communication.
  • Perform other duties as assigned.
Requirements

Minimum Qualifications (required vs. preferred):

PREFERRED:

·         Experience in a clinical diagnostic laboratory, in a facility holding NYS DOH accreditation.

  • Thorough working knowledge of OSHA, CAP, CLIA, and NYS regulatory standards.
  • Post-graduate degree in relevant area

REQUIRED:

·         Experience in a clinical diagnostic laboratory, in a facility holding CAP accreditation.

  • Bachelor’s degree in medical technology, chemistry, biology, or related science.
  • Four years clinical laboratory or quality compliance experience.
  • 1 year of management and leadership experience
  • Excellent communication, computer and writing skills.

 

About Our Organization

GeneDx is rapidly growing CLIA-Certified diagnostic genetics laboratory. We provide cutting edge technologies for genetic molecular diagnostics and offer vital, new-platform products in the critical area of molecular diagnostics. 

 

GeneDx’s success is due to our diverse and talented workforce. If you are looking for a company where you have the opportunity to contribute to the exciting field of molecular diagnosis for rare genetic diseases and prenatal diagnosis then GeneDX is the company for you.