Quality Systems Specialist II(Hybrid)

GeneDx•Gaithersburg, MD

6d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

Experience with New York State-licensed laboratory preferred.
Certification in quality management (e.g., ASQ Certified Quality Auditor, Certified Quality Engineer), preferred.

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/ IVD R-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.