GeneDx is seeking a Director, Quality Systems (FT, 40 hours) to work at our Gaithersburg, MD location, Monday through Friday, 8:30 a.m. to 5:00 p.m.
GeneDx is a rapidly growing CAP and CLIA certified diagnostic genetics laboratory for molecular genetics. Our historic mission has been to make clinical diagnostic testing available for people with genetic conditions and their families. We apply cutting edge technologies that provide a wide array of molecular genetic diagnostic tests, including whole exome sequencing, and next-generation sequencing panels. We specialize in genetic testing for rare hereditary disorders, but also test for common disorders. To learn more about GeneDx, please visit our website at: www.GeneDX.com .
Role: The Quality Systems Director is 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 accreditation 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.