Principal Quality Engineer
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Job Description
Principal Quality Engineer strengthening GeneDx’s IVD quality systems for genomic diagnostics. Leading regulatory compliance, audits, risk management, supplier quality, and continuous improvement.
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
- Remediate identified systemic quality-system gaps
- Translate regulatory and standards requirements into practical, scalable quality processes, procedures, templates, and governance mechanisms
- Serve as the senior Quality representative in product-development, risk-management, design-review, change-control, and lifecycle-governance forums
- Identify, assess, document, and escalate significant quality, compliance, product-safety, and risk-based issues
- Provide functional direction, technical oversight, and coaching to Quality personnel
- Partner with the Director, IVD Regulatory and Quality on priorities, workload allocation, and performance feedback
- Review or ensure review and approval of critical quality-system procedures, significant quality-risk decisions, CAPAs, audit and inspection responses, and management-review outputs
- Establish and monitor QMS performance metrics and quality objectives
- Lead quality-governance and management-review activities, including action tracking and assessment of adverse trends or systemic process gaps
- Oversee supplier-quality strategy and execution, including supplier risk classification, qualification standards, and escalation of critical supplier-quality risks
- Lead audit and inspection readiness, including preparation, hosting, response development, CAPA follow-up, and regulatory monitoring
- Build and sustain a culture of quality, accountability, and continuous improvement across cross-functional teams
Requirements:
- 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
- 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 ISO 13485, ISO 14971, IEC 62304, and 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
- Strong judgment and ability to apply a risk-based, practical approach to quality and compliance
- Excellent written and verbal communication skills, including explaining quality requirements to technical and non-technical stakeholders
- Ability to lead multiple complex initiatives in a fast-paced, cross-functional environment
- Ability to travel up to 20% of the time, including occasional domestic and international travel
- ASQ CQA and/or ISO 13485 Lead Auditor certification strongly preferred
- Experience with the Ketryx platform or similar connected lifecycle management / automated compliance tools is a plus
Benefits:
- Competitive compensation and benefits reflecting local market practices and legal requirements in each country where GeneDx operates
- Fully remote work from a home office or other suitable remote location
- Standard Monday–Friday work hours, 9 AM–5 PM EST
- Work equipment including computer, phone, and video conferencing tools
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