Is Senior Quality Engineer at GeneDx a remote job?

Yes, Senior 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 Senior Quality Engineer at GeneDx?

The listed pay range for this role is $131k–145.1k/yr.

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

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GeneDx

Senior Quality Engineer

Develop QMS processes for IVD products

The Senior Quality Engineer supports development and maintenance of QMS processes for IVD products, ensuring compliance with regulatory requirements. The role involves providing Quality review and guidance to cross-functional teams.

Why This Role?

Work in close partnership with senior IVD Quality team members

Key Responsibilities

Execute IVD QMS activities
Ensure lifecycle processes are operationalized and maintained
Provide Quality review and guidance to cross-functional teams

Requirements

QMS processes knowledge
Regulatory requirements understanding
Quality engineering experience

Required Skills

quality-assuranceregulatory-complianceivdsoftware-qualityprocess-improvementQuality EngineeringRegulatory ComplianceQMS Processes

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   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  <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Execute assigned IVD QMS and product-development activities, ensuring that lifecycle processes are operationalized and maintained in compliance with established standards. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Draft, revise, route for review and approval, and maintain SOPs, work instructions, forms, templates, and other controlled quality-system documentation. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1">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. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1">Compile and analyze assigned Quality metrics and prepare inputs for Quality-governance and management-review activities. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1">Identify process gaps, compliance risks, and improvement opportunities; recommend and help implement practical, risk-based solutions. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1">Support supplier-quality activities as assigned, including supplier documentation, design-transfer readiness, supplier change assessments, and supplier corrective-action follow-up.  </li> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1">Promote a culture of quality, accountability, continuous improvement, and cross-functional collaboration. </li> </ul>   Education, Experience, and Skills  <ul> <li>A bachelor’s or advanced degree in a scientific, engineering, technical, or related discipline (e.g., Biology, Chemistry, Biomedical Engineering, Medical Technology).</li> <li>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. </li> <li>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.</li> <li>Expertise in technical writing and QMS development; demonstrated experience drafting, revising, and implementing Standard Operating Procedures (SOPs), work instructions, and quality templates. </li> <li>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.</li> <li>Experience using Ketryx or similar connected lifecycle management and automated compliance tools for traceability and lifecycle management is a plus.</li> <li>Experience supporting regulatory submissions and audits/inspections. </li> <li>Ability to manage multiple projects and priorities in a fast-paced environment.</li> </ul>   Certificates, Licenses, Registrations    <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">ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Internal Auditor, and/or ISO 13485 Lead Auditor certification preferred. </li> </ul>   Work Environment   <ul> <li data-leveltext="" data-font="Symbol" data-listid="9" 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">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":1080,"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> #LI-REMOTE<div class="content-pay-transparency"><div class="pay-input"><div class="title">Pay Transparency, Budgeted Range</div><div class="pay-range">$131,037—$145,147 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 $195k/yr (range $13.4k–450k/yr, n=403 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

$131k–145.1k/yr

Job Type

full time

Location

Remote · US East hours

~0h overlap with Jakarta hours

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Frequently asked questions

Is Senior Quality Engineer at GeneDx a remote job?: Yes, Senior 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 Senior Quality Engineer at GeneDx?: The listed pay range for this role is $131k–145.1k/yr.
What type of employment is Senior 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.