Quality Systems Specialist II(Hybrid)

GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com.

Summary

The Quality Systems Specialist II is responsible for supporting, maintaining, and improving the Quality Management System (QMS) at GeneDx. This role involves greater autonomy and leadership in driving compliance, facilitating audits, managing key quality programs, and leading process improvement initiatives. The Specialist II works cross-functionally with all departments to ensure adherence to company policies, regulatory standards, and industry best practices, while also mentoring junior team members and leading complex quality projects.

Job Responsibilities

• Quality Management System (QMS) & Conformity:
• Acts as subject matter expert (SME) for multiple quality processes, providing cross-departmental guidance on areas of ownership.
• Ensures adherence to regulatory requirements (e.g., CAP, CLIA, CLEP, FDA, ISO, GxP) and company policy and procedures.
• Proactively identify areas of quality improvement and risk mitigation.
• Experience supporting FDA-regulated IVD products, including an understanding of 21 CFR 820/IVDR-aligned quality system expectations.
• Familiarity with Design Control requirements (user needs, design inputs/outputs, verification/validation, risk management, transfer).
• Hands-on involvement with DHF/DTF/DMR documentation, change control, and document lifecycle management.
• Experience with production and process controls for IVD assays, reagents, or instruments, including lot release documentation, stability, and specification management.
• Audit Support:
• Leads internal audits and assists in external audits, including regulatory inspections and certification audits.
• Prepares audit documentation, coordinates department responses, and drives audit closure.
• Tracks and support timely resolution of audit findings and non-conformances.
• Document Control:
• Manages controlled documents, including standard operating procedures (SOPs), work instructions, etc. for processes they own.
• Non-Conformance & CAPA Management:
• Oversees tracking and resolution of company non-conforming events and corrective and preventive action plans.
• Supports the investigation, root cause analysis, and resolution of quality issues.
• Ensures timely documentation and drives progress toward closure of quality non-conformances.

• Training & Mentorship:
• Ensures adherence to quality procedures and policies, provides guidance on regulatory requirements, and promotes best practices across departments.
• Develops and delivers training programs on quality policies, procedures, and regulatory compliance.
• Acts as mentor to other quality specialist(s), providing guidance on regulatory and QMS requirements.
• Risk & Supplier Management:
• Assists in coordinating supplier management programs, including supplier evaluation, quality performance monitoring, and risk mitigation.
• Oversees complex failure investigations, ensuring timely resolution and reporting.
• Collaborates with cross-functional teams to drive supplier quality improvements.
• Continuous Improvement:
• Identifies and mitigates quality risks to ensure continuous compliance. Participates in process improvement initiatives to enhance product and service quality.
  

People Manager

• This role does not have supervisory responsibilities.
  
  

Education, Experience, And Skills

• Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Quality Management, or similar).
• Minimum 3-5 years of experience in regulated industry such as clinical laboratories, medical devices, healthcare, or pharmaceuticals.
• Experience in quality assurance, quality systems, or regulatory compliance.
• Familiarity with regulatory requirements such as FDA, ISO 9001, ISO 13485, CAP, CLIA, CLEP, and/or GxP.
• Strong organizational, problem-solving, and analytical skills.
• Excellent written and oral communication skills.
• Experience with New York State-licensed laboratory preferred.
  
  

Certificates, Licenses, Registrations

• Certification in quality management (e.g., ASQ Certified Quality Auditor, Certified Quality Engineer), preferred.
  
  

Physical Demands

• Example: Ability to stand, walk, and sit for extended periods.
  
  

Work Environment

• Work is primarily performed in an office setting with a typical climate-controlled environment.
• Occasional exposure to manufacturing or warehouse areas, which may involve loud noises, dust, and varying temperatures.
• This role may require occasional travel to client sites, with potential exposure to outdoor weather conditions.
• Standard work hours are Monday through Friday, 8 AM to 5 PM EST.
  
  

Pay Transparency, Budgeted Range

$78,408—$90,000 USD

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Science - Minded, Patient - Focused.

At GeneDx, we create, follow, and are informed by cutting-edge science. With over 20 years of expertise in diagnosing rare disorders and diseases, and pioneering work in the identification of new disease-causing genes, our commitment to genetic disease detection, discovery, and diagnosis is based on sound science and is focused on enhancing patient care.

Experts In What Matters Most.

With hundreds of genetic counselors, MD/PhD scientists, and clinical and molecular genomics specialists on staff, we are the industry’s genetic testing experts and proud of it. We share the same goal as healthcare providers, patients, and families: to provide clear, accurate, and meaningful answers we all can trust.

SEQUENCING HAS THE POWER TO SOLVE DIAGNOSTIC CHALLENGES.

From sequencing to reporting and beyond, our technical and clinical experts are providing guidance every step of the way:

TECHNICAL EXPERTISE

• High-quality testing: Our laboratory is CLIA certified and CAP accredited and most of our tests are also New York State approved.
• Advanced detection: By interrogating genes for complex variants, we can identify the underlying causes of conditions that may otherwise be missed.
  
  

CLINICAL EXPERTISE

• Thorough analysis: We classify variants according to our custom adaptation of the most recent guidelines. We then leverage our rich internal database for additional interpretation evidence.
• Customized care: Our experts review all test results and write reports in a clear, concise, and personalized way. We also include information for research studies in specific clinical situations.
• Impactful discovery: Our researchers continue working to find answers even after testing is complete. Through both internal research efforts and global collaborations, we have identified and published hundreds of new disease-gene relationships and developed novel tools for genomic data analysis. These efforts ultimately deliver more diagnostic findings to individuals.
  
  

Learn more About Us here.

Our Culture

At GeneDx, we are dedicated to cultivating an environment where creativity and innovation thrive. We believe in the power of community and collaboration, where diverse perspectives are embraced, and every voice contributes to our shared success. Our team is a vibrant mix of professionals who challenge and support each other in equal measure, fostering growth both personally and professionally. When you join us, you're not just taking on a job—you're joining a movement. A movement that champions curiosity, embraces change, and believes in making an impact, one patient at a time. Cultural principles we live by:  

• Be bold in our vision & brave in our execution. 
• Communicate directly, with empathy. 
• Do what we say we're going to do.  
• Be adaptable to change.  
• Operate with a bias for action.  
  
  

Benefits include:

• Paid Time Off (PTO)
• Health, Dental, Vision and Life insurance
• 401k Retirement Savings Plan
• Employee Discounts
• Voluntary benefits
  
  

GeneDx is an Equal Opportunity Employer.

All privacy policy information can be found here.