Director Quality Systems

Gene Dx is a rapidly growing CAP and CLIA certified diagnostic genetic testing 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. To learn more about Gene Dx, please visit our website at

Gene Dx 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.

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.

Essential Duties:

• 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.

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.

All your information will be kept confidential according to EEO guidelines.

Benefits include:

• Paid Time Off (vacation, sick, personal, holiday, jury duty, bereavement leave)
• Health, dental, vision, life insurance, LT/ST disability plans
• Flexible Spending Account (FSA)
• Health Savings Account (HSA)
• 401K retirement savings plan with a 4% company match and immediate vesting
• Tuition Assistance
• Employee Discounts (cell phone service, movie tickets, etc.)
• Many promotions from within

Business casual, dog-friendly work environment