---
title: 'Senior Quality Engineer at GeneDx'
canonical: 'https://feeny.ai/job/senior-quality-engineer-genedx-remote-y5j9amfpmr2p'
type: 'job'
last_seen: '2026-09-04'
---

# Senior Quality Engineer at GeneDx

- **Company:** GeneDx
- **Location:** Remote
- **Compensation:** $131k–$145k
- **Work type:** remote
- **Posted:** 2026-09-02
- **Last confirmed live:** 2026-09-04
- **Apply:** https://genedx.com/careers/openings?gh_jid=4730146005

## Job description

Summary

The Senior Quality Engineer, IVD Quality supports the development, implementation, and maintenance of product-development QMS processes for GeneDx’s IVD and software-enabled IVD products, including design controls, risk management, design transfer, and related lifecycle processes. 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 assigned product core teams, the Senior Quality Engineer provides Quality review, guidance, and process support to ensure that cross-functional activities and supporting technical documentation meet established QMS, regulatory, and standards requirements.

Job Responsibilities

- Execute assigned IVD QMS and product-development activities, ensuring that lifecycle processes are operationalized and maintained in compliance with established standards.
- Draft, revise, route for review and approval, and maintain SOPs, work instructions, forms, templates, and other controlled quality-system documentation.
- Serve as the Quality representative on assigned product core teams and cross-functional working groups; provide practical Quality input, identify quality-system gaps, and escalate significant Quality, compliance, product-safety, and risk-based issues to the Director, IVD Regulatory and Quality, as appropriate.
- Support implementation and execution of design-control processes, including design plans, design inputs and outputs, design reviews, traceability, verification and validation documentation, design transfer documentation, and design-history-file records.
- Facilitate and review risk-management activities and documentation, including risk-management plans, risk assessments, risk controls, residual-risk documentation, and traceability to verification and validation activities.
- Support change-control, nonconformance, deviation, CAPA, complaint-handling, and post-market quality processes, including investigation documentation, root-cause analysis, action tracking, effectiveness checks, and trend reporting.
- Support internal audits, external audits, and inspection readiness for assigned areas by preparing objective evidence, participating in audits, tracking corrective actions, and assisting with responses to observations or requests.
- Compile and analyze assigned Quality metrics and prepare inputs for Quality-governance and management-review activities.
- Identify process gaps, compliance risks, and improvement opportunities; recommend and help implement practical, risk-based solutions.
- Support supplier-quality activities as assigned, including supplier documentation, design-transfer readiness, supplier change assessments, and supplier corrective-action follow-up.
- Promote a culture of quality, accountability, continuous improvement, and cross-functional collaboration.

Education, Experience, and Skills

- A bachelor’s or advanced degree in a scientific, engineering, technical, or related discipline (e.g., Biology, Chemistry, Biomedical Engineering, Medical Technology).
- Minimum of 6 years of Quality Engineering or Quality Assurance experience, with at least 4 years specifically within an IVD, molecular diagnostics, or medical device regulated environment.
- Practical experience applying quality-system and product-development requirements in a regulated environment, including FDA quality-system requirements, ISO 13485, ISO 14971, IEC 62304, and IEC 62366, as applicable.
- Expertise in technical writing and QMS development; demonstrated experience drafting, revising, and implementing Standard Operating Procedures (SOPs), work instructions, and quality templates.
- Strong understanding of the product development lifecycle, with experience serving on cross-functional core teams to ensure design history files and technical justifications are compliant and audit-ready.
- Experience using Ketryx or similar connected lifecycle management and automated compliance tools for traceability and lifecycle management is a plus.
- Experience supporting regulatory submissions and audits/inspections.
- Ability to manage multiple projects and priorities in a fast-paced environment.

Certificates, Licenses, Registrations

- ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Internal Auditor, and/or ISO 13485 Lead Auditor certification 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 $131,037—$145,147 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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