Remote Principal Quality Engineer — IVD QMS & Compliance

Socket.dev; United States; On-site; USD 150,000 - 169,000; Full time

Job summary

GeneDx is seeking a Principal Quality Engineer, IVD Quality to lead the IVD QMS implementation and ongoing improvement, ensuring processes are risk-based, scalable, and embedded across product development. Collaborate with Regulatory, Development, Software, Product, Clinical/Medical Affairs, and Cybersecurity to maintain FDA and ISO-aligned quality systems.

The role includes leading governance, CAPA, audits, supplier quality, and inspection readiness, with remote work and travel up to 20%.

Qualifications

• Bachelor’s degree in a scientific, engineering, technical, or related discipline.
• 10+ years in quality assurance or quality systems in a regulated environment, with 6+ years in IVD/medical devices.
• Strong working knowledge of FDA quality-system requirements and ISO 13485, 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 and ISO audits.
• Experience with the Ketryx platform or similar connected lifecycle management / automated compliance tools is a plus.

Responsibilities

• Lead development and execution of the IVD QMS implementation roadmap, including milestones, cross-functional dependencies, resource needs, and status reporting.
• Establish, maintain, and continuously improve the IVD quality management system (QMS) to support compliant product development and remediation of identified systemic gaps.
• Translate regulatory and standards requirements into practical, scalable quality processes, procedures, templates, and governance mechanisms 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 significant quality, compliance, product-safety, and risk-based issues are identified, assessed, documented, and escalated.
• Provide direction and coaching to Quality personnel; partner on priorities, workload allocation, and performance feedback.
• Review and approve quality-system procedures, significant quality-risk decisions, CAPAs, audit and inspection responses, and management-review outputs.
• Establish and monitor QMS performance metrics and lead quality-governance and management-review activities.
• Oversee supplier-quality strategy and execution; provide technical direction to the Quality Engineer who executes supplier qualification, monitoring, and audits.
• Lead audit and inspection readiness, including preparation, hosting, response development, CAPA follow-up, and monitoring changes to regulations and standards.
• Build and sustain a culture of quality, accountability, and continuous improvement across cross-functional teams.

Skills

Quality systems

Regulatory knowledge

Leadership

Cross-functional collaboration

Risk-based thinking

Quality assurance

Auditing

Education

Bachelor’s degree in a scientific/engineering discipline

Advanced degree preferred

Tools

Ketryx platform

Job description

GeneDx is seeking a Principal Quality Engineer, IVD Quality to lead the IVD QMS implementation and ongoing improvement, ensuring processes are risk-based, scalable, and embedded across product development. Collaborate with Regulatory, Development, Software, Product, Clinical/Medical Affairs, and Cybersecurity to maintain FDA and ISO-aligned quality systems.

The role includes leading governance, CAPA, audits, supplier quality, and inspection readiness, with remote work and travel up to 20%.