Quality Systems Director
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.
- 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.