Director Quality Systems

GeneDx, Inc; Gaithersburg (MD); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Paid Time Off

Health insurance

401K with company match

Tuition Assistance

Employee Discounts

Job summary

GeneDx, Inc is seeking a Director, Quality Systems in Gaithersburg, MD to manage all functions within Quality Systems including quality control programs and audits. The role demands strong leadership and experience in clinical diagnostic laboratories and regulatory standards.

Ideal candidates will have a Bachelor's degree in a related science and significant quality compliance experience. Benefits include comprehensive health insurance, PTO, and a 401K plan with company match.

Qualifications

• Experience in a clinical diagnostic laboratory with CAP accreditation.
• At least four years of clinical laboratory or quality compliance experience.
• Minimum of one year management and leadership experience.

Responsibilities

• Plan, coordinate and oversee functions within Quality Systems.
• Develop and implement quality control and monitoring programs.
• Perform internal quality audits and follow up with actions.

Skills

Clinical laboratory experience

Quality compliance knowledge

Management and leadership

Education

Bachelor's degree in medical technology, chemistry, biology, or related science

Job description

GeneDx 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 GeneDx, please visit our website at www.genedx.com.

Job Description

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.

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.

Qualifications

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.

Additional Information

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

Job Location