Principal Quality Engineer

🔥 17 hours ago

🇺🇸 United States – Remote

💵 $150.5k - $168.7k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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GeneDx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

🏥 Healthcare

🤖 Artificial Intelligence

Biotechnology • Healthcare • Artificial Intelligence

GeneDx is a biotechnology company dedicated to providing personalized and targeted medical care through genetic diagnosis. Leveraging one of the largest datasets for rare diseases, GeneDx offers advanced testing such as whole genome and exome sequencing. Their diagnostic solutions translate complex genomic information into actionable insights, facilitating personalized health plans, enhancing drug discovery, and improving the efficiency of healthcare systems.

📋 Description

• 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