Principal Quality Engineer

🕒 September 2

🇺🇸 United States – Remote

💵 $150.5k - $168.7k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 27%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 73 days.
• Jobs at this company usually fill in 30 days.
• Reposted once.

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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

• Implement, maintain, and continuously improve the IVD quality management system • Lead the IVD QMS implementation roadmap, including prioritization, milestones, dependencies, resources, and status reporting • Translate regulatory and standards requirements into scalable quality processes, procedures, templates, and governance mechanisms • Provide quality oversight and escalation support for IVD product development with Regulatory Affairs, R&D, Software Development, Product, Clinical/Medical Affairs, and Cybersecurity • Serve as senior Quality representative in product-development, risk-management, design-review, change-control, and lifecycle-governance forums • Provide functional direction, technical oversight, and coaching to Quality personnel • Review or oversee approval of critical quality-system procedures, 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 • Oversee supplier-quality strategy, 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, including at least 6 years 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 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, to conduct supplier audits and support supplier qualification activities • Experience with the Ketryx platform or similar connected lifecycle management / automated compliance tools is a plus • ASQ CQA and/or ISO 13485 Lead Auditor certification strongly preferred

🏖️ Benefits

• Competitive compensation and benefits reflecting local market practices and legal requirements • Fully remote work from a home office or other suitable remote location • Standard work schedule of Monday through Friday, 9 AM to 5 PM EST • Flexible adjustment of work schedule and hours in collaboration with the leader and evolving business needs

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