---
title: 'Software Quality Engineer at GeneDx'
canonical: 'https://feeny.ai/job/software-quality-engineer-genedx-remote-v5995hq7w39d'
type: 'job'
last_seen: '2026-09-04'
---

# Software Quality Engineer at GeneDx

- **Company:** GeneDx
- **Location:** Remote
- **Compensation:** $111k–$123k
- **Work type:** remote
- **Posted:** 2026-09-02
- **Last confirmed live:** 2026-09-04
- **Apply:** https://genedx.com/careers/openings?gh_jid=4730153005

## Job description

Summary

- The Software Quality Engineer, IVD Quality supports the development, implementation, and maintenance of software-specific QMS processes, including Software Development Life Cycle (SDLC), Software Risk Management, and Cybersecurity, for GeneDx’s IVD and digital products. The role reports to the Director, IVD Regulatory and Quality and works in close partnership with senior members of the IVD Quality team.
- Serving as the Quality representative on software development and bioinformatics teams, the Software Quality Engineer provides Quality review, guidance, and process support to ensure that software engineering activities and supporting technical documentation meet established QMS, regulatory, and standards requirements (e.g., IEC 62304 and ISO 62366).

Job Responsibilities

- Execute assigned software-development Quality activities and support the build-out of associated SDLC  QMS processes.
- Provide Quality review and process oversight for software design-control activities, including software requirements, architecture documentation, code-review records, and verification and validation documentation, to support compliance and audit readiness.
- Participate in the development and review of Design and Development File documentation throughout the product lifecycle.
- Serve as the Quality representative for software risk-management activities, providing guidance and review throughout the software lifecycle.
- Provide Quality support for validation of non-product software tools used in operations, product testing, and the quality system.
- Support the investigation and resolution of software-related nonconformances, deviations, and CAPAs.
- Provide Quality input on cybersecurity-related design-control, risk-management, vulnerability-management, and post-market activities to support alignment with applicable FDA cybersecurity guidance and established QMS requirements.
- Support internal and external audits by preparing software-related objective evidence and assisting with responses to findings.
- Monitor evolving regulatory expectations, standards, and best practices for software in IVDs, including FDA and international guidance; recommend updates to applicable processes and documentation.
- Contribute to continuous improvement initiatives related to software development and quality processes.

Education, Experience, and Skills

- A bachelor’s or advanced degree in a relevant scientific or technical field (e.g., Computer Science, Engineering, Bioinformatics).
- 6+ years of software QA experience, with 4+ years in medical device or FDA-regulated software development.
- Practical experience with design controls, ISO 13485, ISO 14971, IEC 62304 regulations.
- Experience with Software as a Medical Device or medical devices containing software. Strong understanding of design control procedures and the software development lifecycle in regulated environments.
- Experience supporting regulatory submissions and audits.
- Ability to manage multiple projects and priorities in a fast-paced environment.

Certificates, Licenses, Registrations

- Certified Software Quality Engineer (CSQE) 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.

## #LI-REMOTE

Pay Transparency, Budgeted Range $111,249—$122,620 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)

## Other roles at GeneDx

- [RCM Client Billing Specialist](https://feeny.ai/job/rcm-client-billing-specialist-genedx-remote-23trcertkj4x)
- [RCM Client Billing Manager](https://feeny.ai/job/rcm-client-billing-manager-genedx-remote-ne10ebpahcry)
- [Facilities Lead](https://feeny.ai/job/facilities-lead-genedx-gaithersburg-maryland-j91xcwpwrraj) — Gaithersburg Maryland, United States
- [Clinical Billing Integrity Lead Analyst](https://feeny.ai/job/clinical-billing-integrity-lead-analyst-genedx-remote-g63wc6z7h9qc)
- [Talent Acquisition Partner](https://feeny.ai/job/talent-acquisition-partner-genedx-remote-jx24w6j7q3rr)
- [Quality Engineer](https://feeny.ai/job/quality-engineer-genedx-remote-d5f6pz7y5xya)
- [Principal Quality Engineer](https://feeny.ai/job/principal-quality-engineer-genedx-remote-94623gmakvvt)
- [Senior Quality Engineer](https://feeny.ai/job/senior-quality-engineer-genedx-remote-y5j9amfpmr2p)
- [Sr Director, Business Finance](https://feeny.ai/job/sr-director-business-finance-genedx-remote-2zhh4wf1qk0j)
- [Regional Account Executive - General Pediatrics (Long Island & Queens)](https://feeny.ai/job/regional-account-executive-general-pediatrics-long-island-queens-genedx-remote-h1hj8m0hhfdz)