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Quality Systems Jobs in Washington (NOW HIRING)

GeneDx, Inc

Director Quality Systems

Gaithersburg, MD · On-site

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 ...

Fibox Inc.

Quality Engineer

Glen Burnie, MD · On-site

$69K - $90K/yr

This position is responsible for driving continuous improvement, leading root cause analysis, and implementing effective quality systems within a fast-paced manufacturing environment. The Quality ...

TRI Challenge Convention

PRINCIPAL, QA

Bethesda, MD

... System Conduct external audits at clinical sites and vendor sites Leads process improvement activities and CAPA investigations Reviews clinical quality management plans and provides consultative ...

CYNET SYSTEMS

Quality Engineer

Columbia, MD · On-site

$47 - $52/hr

Technical specialization in change management and data integrity, systems development/validation ... Proficiency in the use of modern technology, especially electronic quality management systems ...

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Quality Systems information

What is a quality system?

Quality Systems are structured processes and procedures that organizations establish to ensure their products or services consistently meet defined quality standards and regulatory requirements. These systems typically include documentation, training, auditing, corrective actions, and continuous improvement practices. Quality Systems are essential in industries like manufacturing, pharmaceuticals, and healthcare to maintain compliance and customer satisfaction. Implementing a robust Quality System helps organizations minimize errors, improve efficiency, and comply with industry regulations.

How does a quality systems professional typically collaborate with other departments to maintain compliance and improve processes?

Quality Systems professionals work closely with departments like Manufacturing, Regulatory Affairs, and Research & Development to ensure that quality standards and compliance requirements are consistently met. They facilitate communication between teams, conduct audits, and coordinate corrective actions to address any issues. Collaboration often involves leading training sessions, reviewing documentation, and implementing continuous improvement initiatives based on feedback from various stakeholders. This cross-functional teamwork is essential for maintaining certifications and driving process excellence throughout the organization.

What are the key skills and qualifications needed to thrive as a quality systems professional, and why are they important?

To thrive as a Quality Systems professional, a solid understanding of quality management principles, process improvement methodologies, and compliance standards such as ISO 9001 is essential, often supported by a relevant degree or certification. Familiarity with quality management software (QMS), audit tools, and document control systems is typically required. Strong attention to detail, problem-solving abilities, and effective communication are vital soft skills that distinguish top performers in this role. These capabilities are crucial for maintaining regulatory compliance, driving continuous improvement, and ensuring consistent product or service quality.

What is the difference between Quality Systems vs Quality Assurance?

AspectQuality SystemsQuality Assurance
FocusDeveloping, implementing, and maintaining quality management systemsMonitoring and verifying product quality through audits and inspections
CertificationsISO 9001, ISO 13485, QS standardsISO 9001, industry-specific standards
Work EnvironmentQuality departments, compliance teamsProduction lines, inspection units
Employer UsageManufacturers, healthcare, aerospaceManufacturers, service providers

While both roles aim to ensure product quality, Quality Systems focuses on establishing and maintaining the overall quality management framework, whereas Quality Assurance emphasizes verifying and validating that products meet quality standards through testing and inspections.

What does a quality systems specialist do?

A quality systems specialist develops, implements, and maintains quality management systems to ensure products and processes meet industry standards and regulations. They analyze data, conduct audits, and collaborate with teams to improve quality and compliance, often using tools like ISO standards and quality software. Certification in quality management, such as ISO 9001, is common in this role.

What are the most commonly searched types of Quality Systems jobs in Washington?

The most popular types of Quality Systems jobs in Washington are:

What are popular job titles related to Quality Systems jobs in Washington?

For Quality Systems jobs in Washington, the most frequently searched job titles are:

What job categories do people searching Quality Systems jobs in Washington look for?

The top searched job categories for Quality Systems jobs in Washington are:

What cities in Washington are hiring for Quality Systems jobs?

Cities in Washington with the most Quality Systems job openings:

Quality Systems jobs near you
Infographic showing various Quality Systems job openings in Washington as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 10% Part Time, 2% Temporary, 8% Contract, and 1% Nights. Highlights an 82% Physical, 2% Hybrid, and 16% Remote job distribution.

Director Quality Systems

GeneDx, Inc

Gaithersburg, MD

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted yesterday

GeneDx rating

9.3

Company rating: 9.3 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

4th of 120 rated laboratories

Job description

Company 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.)
  • Regular performance appraisals
  • Many promotions from within

Business casual, dog-friendly work environment

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