Is Principal Quality Engineer at GeneDx a remote job?

Yes, Principal Quality Engineer at GeneDx is remote, but the employer did not state which countries can apply. Check the listing before applying.

What is the salary for Principal Quality Engineer at GeneDx?

The listed pay range for this role is $150.5k–168.7k/yr.

Click the "Apply" button on this page to go to the official application at GeneDx.

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GeneDx

Principal Quality Engineer

Develop scalable quality management systems

Implement and maintain IVD quality management systems, ensuring practical and risk-based processes. The Principal Quality Engineer reports to the Director, IVD Regulatory and Quality.

Why This Role?

Report to the Director, IVD Regulatory and Quality

Key Responsibilities

Implement IVD quality management systems
Provide quality oversight for IVD product development
Partner with Regulatory Affairs and Development Lab/R&D

Requirements

IVD quality management system experience
Knowledge of FDA requirements and ISO standards
Quality engineering expertise

Required Skills

quality-managementregulatory-complianceivdfdaisocommunicationQuality EngineeringRegulatory ComplianceRisk Management

Indonesia Context

Working Hours Overlap:: Minimal overlap — opposite hours

See remote (USD) vs local pay →

View Original Description from Greenhouse BoardsShow more

Original description from Greenhouse Boards

Summary   <ul> <li data-leveltext="" data-font="Symbol" data-listid="17" data-list-defn-props="{"335552541":1,"335559685":1440,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="17" data-list-defn-props="{"335552541":1,"335559685":1440,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">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. </li> </ul>   Job Responsibilities  <ul> <li data-leveltext="•" data-font="Calibri" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Calibri","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Lead development and execution of the IVD QMS implementation roadmap, including process prioritization, milestones, cross-functional dependencies, resource needs, and status reporting. </li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Calibri","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Establish, maintain, and continuously improve the IVD quality management system (QMS), ensuring it supports compliant product development and remediation of identified systemic gaps. </li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Calibri","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Calibri","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Calibri","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Calibri","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Calibri","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Calibri","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Calibri","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1">Lead audit and inspection readiness, including preparation, hosting, response development, CAPA follow-up, and monitoring of changes to applicable regulations, guidance, and standards. </li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="21" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Calibri","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1">Build and sustain a culture of quality, accountability, and continuous improvement across cross-functional teams. </li> </ul>   Education, Experience, and Skills  <ul> <li>Bachelor’s degree in a scientific, engineering, technical, or related discipline required; advanced degree preferred.</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">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.<span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559740":240,"335559991":360,"469777462":[720],"469777927":[0],"469777928":[1]}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Direct experience implementing or maintaining a quality management system supporting IVDs, molecular diagnostics, and/or software-enabled medical devices. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="18" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Strong working knowledge of applicable FDA quality-system requirements and relevant standards, including: ISO 13485, ISO 14971, IEC 62304, IEC 62366 </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="18" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1">Experience with FDA-regulated product development, design controls, risk management, software lifecycle controls, and post-market quality processes. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="18" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1">Experience supporting FDA inspections, ISO audits, regulatory submissions, and audit-response activities. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="19" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Experience with the Ketryx platform or similar connected lifecycle management / automated compliance tools is a plus. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="19" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Strong judgment and ability to apply a risk-based, practical approach to quality and compliance. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="18" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1">Excellent written and verbal communication skills, including the ability to explain quality requirements to technical and non-technical stakeholders. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="18" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1">Ability to lead multiple complex initiatives in a fast-paced, cross-functional environment.   </li> </ul> Certificates, Licenses, Registrations   <ul> <li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">ASQ CQA and/or ISO 13485 Lead Auditor certification strongly preferred. </li> </ul> Work Environment   <ul> <li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":1440,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":1440,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Standard work hours are Monday through Friday, 9 AM to 5 PM EST. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":1440,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">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> </ul> #LI-REMOTE<div class="content-pay-transparency"><div class="pay-input"><div class="title">Pay Transparency, Budgeted Range</div><div class="pay-range">$150,458—$168,715 USD</div></div></div><div class="content-conclusion"><div class="column _8-col center-element _12-col-tab"> <div class="margin-bottom margin-24"> <h3 class="heading-l">A culture that plays to win, because patients are counting on us</h3> </div> </div> <div class="column _8-col _12-col-tab"> 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. <div class="card-number">2. Think bigger (stretch beyond, courage not consensus)</div> We push past the obvious. We challenge assumptions, raise the bar, and make thoughtful, decisive calls — choosing progress over perfection. <div class="card-number">3. Grow fast (be curious, speak up, be agile)</div> 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. </div> <div>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.</div> 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 <a href="https://www.genedx.com/privacy" target="_blank">here</a>.</div>

Salary Context

Similar Engineering roles on LokerDollar pay around $222.5k/yr (range $41k–1000k/yr, n=647 active listings).

Openness not stated by employer — check the listing

The listing does mention EST work hours — check whether that overlap works for you.

Company

GeneDx

Source

Greenhouse Boards

Salary

$150.5k–168.7k/yr

Job Type

full time

Location

Remote · US East hours

~0h overlap with Jakarta hours

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Frequently asked questions

Is Principal Quality Engineer at GeneDx a remote job?: Yes, Principal Quality Engineer at GeneDx is remote, but the employer did not state which countries can apply. Check the listing before applying.
What is the salary for Principal Quality Engineer at GeneDx?: The listed pay range for this role is $150.5k–168.7k/yr.
What type of employment is Principal Quality Engineer at GeneDx?: This is a full time position.
How do I apply?: Click the "Apply" button on this page to go to the official application at GeneDx.