Principal Quality Engineer

Summary  

• The Principal Quality Engineer, IVD Quality is responsible for the implementation, maintenance, and continuous improvement of the IVD quality management system, reporting to the Director, IVD Regulatory and Quality. The role ensures that QMS processes are practical, scalable, risk-based, and effectively embedded into GeneDx operations. 

• The role provides quality oversight and escalation support for IVD product development, partnering with Regulatory Affairs, Development Lab/R&D, Software Development, Product, Clinical/Medical Affairs, and Cybersecurity as needed. The Principal Quality Engineer advises on significant quality, compliance, product-safety, and risk-based issues to help ensure products and supporting evidence remain aligned with applicable FDA requirements, ISO standards, and GeneDx quality-system requirements. 

Job Responsibilities 

• Lead development and execution of the IVD QMS implementation roadmap, including process prioritization, milestones, cross-functional dependencies, resource needs, and status reporting. 

• Establish, maintain, and continuously improve the IVD quality management system (QMS), ensuring it supports compliant product development and remediation of identified systemic gaps. 

• Translate applicable regulatory and standards requirements into practical, scalable quality processes, procedures, templates, and governance mechanisms appropriate for GeneDx’s IVD and software-enabled IVD products. 

• Serve as the senior Quality representative in product-development, risk-management, design-review, change-control, and lifecycle-governance forums; ensure that significant quality, compliance, product-safety, and risk-based issues are identified, appropriately assessed, documented, and escalated. 

• Provide functional direction, technical oversight, and coaching to Quality personnel supporting the IVD QMS and product-development activities; partner with the Director, IVD Regulatory and Quality on priorities, workload allocation, and performance feedback. 

• Review and provide quality approval for, or ensure appropriate review and approval of, critical quality-system procedures, significant quality-risk decisions, CAPAs, audit and inspection responses, and management-review outputs, in accordance with established quality-system governance and delegated approval authority. 

• Establish and monitor QMS performance metrics and quality objectives; lead quality-governance and management-review activities, including preparation of management-review inputs, quality-review meetings, action tracking, assessment of adverse trends or systemic process gaps, and follow-up on quality-system commitments. 

• Oversee supplier-quality strategy and execution, including risk classification, qualification standards, and escalation of critical supplier-quality risks; providing technical direction to the Quality Engineer who executes day-to-day supplier qualification, monitoring, and audit activities. 

• Lead audit and inspection readiness, including preparation, hosting, response development, CAPA follow-up, and monitoring of changes to applicable regulations, guidance, and standards. 

• Build and sustain a culture of quality, accountability, and continuous improvement across cross-functional teams. 

Education, Experience, and Skills 

• Bachelor’s degree in a scientific, engineering, technical, or related discipline required; advanced degree preferred.

• 10+ years of progressive quality assurance or quality systems experience within a regulated environment, with at least 6 years specifically in the IVD or medical device industry. 

• Direct experience implementing or maintaining a quality management system supporting IVDs, molecular diagnostics, and/or software-enabled medical devices. 

• Strong working knowledge of applicable FDA quality-system requirements and relevant standards, including: ISO 13485, ISO 14971, IEC 62304, IEC 62366 

• Experience with FDA-regulated product development, design controls, risk management, software lifecycle controls, and post-market quality processes. 

• Experience supporting FDA inspections, ISO audits, regulatory submissions, and audit-response activities. 

• Experience with the Ketryx platform or similar connected lifecycle management / automated compliance tools is a plus. 

• Strong judgment and ability to apply a risk-based, practical approach to quality and compliance. 

• Excellent written and verbal communication skills, including the ability to explain quality requirements to technical and non-technical stakeholders. 

• Ability to lead multiple complex initiatives in a fast-paced, cross-functional environment.   

Certificates, Licenses, Registrations  

• ASQ CQA and/or ISO 13485 Lead Auditor certification strongly preferred. 

Work Environment  

• This is a fully remote position. The employee will work from a home office or other suitable remote location with reliable high-speed internet access. Work is performed in a climate-controlled environment using standard office equipment including computer, phone, and video conferencing tools. Your standard work schedule and hours will be established in collaboration with your leader and may be adjusted to align with evolving business needs. 

• Standard work hours are Monday through Friday, 9 AM to 5 PM EST. 

• Ability to travel up to 20% of the time, including occasional domestic and international travel, to conduct supplier audits and support supplier qualification activities. 

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