---
title: 'Principal Quality Engineer at GeneDx'
canonical: 'https://feeny.ai/job/principal-quality-engineer-genedx-remote-94623gmakvvt'
type: 'job'
last_seen: '2026-09-04'
---

# Principal Quality Engineer at GeneDx

- **Company:** GeneDx
- **Location:** Remote
- **Compensation:** $150k–$169k
- **Work type:** remote
- **Posted:** 2026-09-02
- **Last confirmed live:** 2026-09-04
- **Apply:** https://genedx.com/careers/openings?gh_jid=4730163005

## Job description

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.

## #LI-REMOTE

Pay Transparency, Budgeted Range $150,458—$168,715 USD

A culture that plays to win, because patients are counting on us​

At GeneDx, we're driven by urgency and purpose: helping patients get diagnosed earlier. Our mission, to empower everyone to live their healthiest life through genomics, drives our team to make a tangible impact each day – and shapes our culture where high standards, strong teamwork, and meaningful ownership are the norm. We act with intention, support one another, and deliver work we're proud to put our names on.​

Here’s what you can expect day to day:​

1. Play like a champion (step up, redefine what’s possible, own it)​

We bring energy, focus, and a bias for action. We step up, take initiative, and deliver on our commitments – with quality, speed, and care.​

1. Think bigger (stretch beyond, courage not consensus)​

We push past the obvious. We challenge assumptions, raise the bar, and make thoughtful, decisive calls — choosing progress over perfection.​

1. Grow fast (be curious, speak up, be agile)​

We stay curious, ask questions, and share direct feedback with respect. We adapt quickly and keep learning through collaboration and continuous improvement.​

If you’re motivated by meaningful work, a fast-moving environment, and teammates who care deeply about outcomes, you’ll thrive at GeneDx.

At GeneDx, we believe in taking care of our people. We provide competitive compensation and benefits that reflect local market practices and legal requirements in each country where we operate, helping employees thrive both professionally and personally.

We welcome everyone regardless of their background. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, age, and other characteristics protected by law.

GeneDx is a place where people from all backgrounds can make an impact.

All privacy policy information can be found [here](https://www.genedx.com/privacy).

## About GeneDx

## Company Overview
- **One-liner**: GeneDx provides advanced genetic testing for rare and inherited diseases, using the world’s largest rare disease dataset to deliver faster, more accurate diagnoses.
- **Entity Type**: Public (NASDAQ: WGS)
- **Headquarters**: Stamford, Connecticut, United States
- **Founded**: 2017
- **Founders**: Not publicly available

## Core Business
- Primary industry: Clinical genomics / rare disease diagnostics
- Target customers: B2B (clinicians, health systems, biopharma partners) and B2C (patients, families via at-home sample collection)
- Mission: “To diagnose any genetic disease as early as possible for more people around the world.” [genedx.com](https://www.genedx.com/why-genedx)

## Products & Services
- **GeneDx Infinity™**: The largest rare disease genomic dataset, with data from over 2.5 million tests, nearly 1 million exomes/genomes, and 7+ million phenotypic data points. Powers all testing and fuels drug discovery. [genedx.com](https://www.genedx.com/)
- **ExomeDx™ & GenomeDx™**: Industry-leading whole exome and whole genome sequencing tests, ranked #1 by pediatric and genetic specialists and granted FDA Breakthrough Device Designation. Available via simple cheek swab with at-home collection. [genedx.com](https://www.genedx.com/)
- **Targeted Panels**: Comprehensive panels for specific conditions, offering rapid results (days to weeks) and actionable insights. [genedx.com](https://www.genedx.com/)
- **Biopharma Services**: Accelerate drug discovery and clinical development using the GeneDx dataset and clinical expertise. [genedx.com](https://www.genedx.com/)

## Market Standing
- **Valuation/Market Cap**: Not publicly available (public company, market cap fluctuates)
- **Key Metric (Annual Revenue)**: $882.5 million (LinkedIn estimate) [linkedin.com](https://www.linkedin.com/company/genedx/life)
- **Total Funding (historical)**: $1.216 billion, including a $121M Series C led by BlackRock Innovation Capital (2020), post-IPO equity rounds, and a $100M venture round in 2025. [linkedin.com](https://www.linkedin.com/company/genedx/life)
- **Notable Investors/Partners**: BlackRock Innovation Capital, Sema4 (parent company). In-network for 79% of commercially insured patients; Medicaid coverage in 36 states. Trusted by over 75,000 clinicians. [genedx.com](https://www.genedx.com/)
- **Growth Signals**: Headcount grew 47% YoY (1,005 employees as of mid-2026); acquired Fabric Genomics (2025); named one of Fast Company’s Most Innovative Companies of 2025. [linkedin.com](https://www.linkedin.com/company/genedx/life) [genedx.com](https://www.genedx.com/careers)

## Competitive Advantages
- **Largest rare disease dataset (GeneDx Infinity™)**: Unmatched scale enables 17% higher diagnostic yield vs. standard testing. [genedx.com](https://www.genedx.com/)
- **Speed and actionability**: Results in days to weeks, with industry-leading classification and genetic counselors available. 60% of diagnosed patients see a change in medical management. [genedx.com](https://www.genedx.com/)
- **Over 25 years of innovation** (cumulative from legacy GeneDx): Discovered 500+ new disease-gene relationships and published 1,000+ scientific papers. [genedx.com](https://www.genedx.com/why-genedx)
- **FDA Breakthrough Device Designation** for core tests, validating clinical utility.

## Strategic Focus
- **Expand access**: Drive adoption of whole exome/genome sequencing as first-line testing for rare disease, growing payer coverage and reducing the diagnostic odyssey.
- **Accelerate drug discovery**: Leverage the dataset to partner with biopharma for therapeutic development.
- **Improve health system efficiencies**: Deliver integrated genomic intelligence to health systems for faster, more cost-effective care. [genedx.com](https://www.genedx.com/why-genedx)

## Why Work Here
- **Culture**: Described as “play like a champion”, “think bigger”, and “grow fast” – with a bias for action and meaningful ownership. Emphasis on urgency and purpose because patients are counting on them. [genedx.com](https://www.genedx.com/careers)
- **Benefits**: Comprehensive medical/dental/vision, virtual visits, behavioral health, 22 weeks fully paid parental leave, up to $25K annually for fertility/adoption/surrogacy, 401k match up to 5%, employee stock purchase plan at 15% discount, 11 paid holidays, competitive PTO, life/disability insurance, and free personal genetic testing. [genedx.com](https://www.genedx.com/careers)
- **Work model**: Not explicitly stated; likely hybrid/office-based given multiple locations (US, Canada, Iceland, UK, etc.). Remote flexibility may vary by role.
- **Engineering & science culture**: Strong focus on bioinformatics, data operations, and clinical research. Recent openings include Director of Bioinformatics Engineering, Product Manager, and Clinical Analyst. [linkedin.com](https://www.linkedin.com/company/genedx/life)
- **Mission-driven**: Every role directly contributes to ending the diagnostic odyssey for children with rare diseases. [genedx.com](https://www.genedx.com/careers)

## Sources
1. [genedx.com](https://www.genedx.com/)
2. [genedx.com](https://www.genedx.com/careers)
3. [genedx.com](https://www.genedx.com/why-genedx)
4. [genedx.com](https://www.genedx.com/careers/openings)
5. [linkedin.com](https://www.linkedin.com/company/genedx/life)

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