Is Quality Engineer at GeneDx a remote job?

Yes, 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 Quality Engineer at GeneDx?

The listed pay range for this role is $84.9k–93.2k/yr.

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

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GeneDx

Quality Engineer

Develop quality processes for IVD products

Implement and maintain supplier-quality and post-market Quality processes for GeneDx's IVD products, working closely with the IVD Quality team.

Why This Role?

Close partnership with senior IVD Quality team members

Key Responsibilities

Implement supplier quality processes
Execute post-market Quality activities
Handle complaints and nonconformances

Required Skills

quality assurancesupplier managementregulatory compliancequality engineeringhealthcareIVD Quality

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="26" 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">The Quality Engineer, IVD Quality supports the implementation, maintenance, and execution of supplier-quality and post-market Quality processes for GeneDx’s IVD and software-enabled IVD products. The role reports to the Director, IVD Regulatory and Quality and works in close partnership with senior members of the IVD Quality team. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="26" 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">This hands-on role is initially focused on supplier quality, including supplier qualification, monitoring, change management, performance monitoring, and supplier-related investigations. The role also executes assigned post-market Quality activities, including complaint handling, nonconformance and deviation management, CAPA support, investigations, and Quality trend reporting. </li> </ul>   Job Responsibilities  <ul> <li data-leveltext="" data-font="Symbol" data-listid="13" 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">Support implementation, maintenance, and continuous improvement of established IVD supplier-quality and post-market quality processes. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="13" 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">Partner with Procurement and other applicable stakeholders to support supplier onboarding, risk classification, qualification, change management, monitoring, and performance management; maintain supplier qualification records, Quality Agreements, and the Approved Supplier List. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="13" 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">Conduct or support supplier audits and assessments; prepare audit reports and track supplier corrective actions to closure. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="13" 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">Evaluate supplier-initiated changes and quality events for potential impact on product quality, supply continuity, or regulatory status; escalate complex or high-risk assessments as appropriate. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="13" 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">Support supplier readiness during design transfer by confirming supplier qualification status, required documentation, and applicable process controls. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="13" 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">Execute assigned post-market quality activities, including complaint intake and investigation support, nonconformances, deviations, CAPAs, quality-event documentation, action tracking, and effectiveness checks. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="13" 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">Investigate supplier-related quality events and assess whether supplier materials, reagents, software, services, or performance may have contributed to a complaint, deviation, nonconformance, or other post-market event. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="13" 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 supplier and post-market quality metrics and support trend reporting, management review, and quality-governance activities. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="13" 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">Draft and maintain supplier-quality and post-market quality procedures, work instructions, forms, templates, and quality records, following established QMS standards. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="13" 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 audit and inspection readiness by organizing objective evidence and responding to requests under the direction of Quality leadership. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="13" 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">Identify process gaps and improvement opportunities within assigned processes and escalate recommendations for broader QMS changes. </li> </ul>   Education, Experience, and Skills  <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" 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">Bachelor’s degree in a scientific, engineering, technical, or related discipline. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" 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">Minimum of 3 years of Quality Engineering, Quality Assurance, supplier quality, or related experience, including at least 2 years within an IVD, molecular diagnostics, medical-device, or similarly regulated environment. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" 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">Experience with supplier qualification, supplier monitoring, quality agreements, supplier corrective actions, supplier change assessments, and supplier performance monitoring. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">Experience supporting at least one post-market quality process, such as complaint handling, nonconformance management, deviation management, CAPA, investigations, or quality trending. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Working knowledge of applicable FDA quality-system requirements, ISO 13485, and ISO 14971. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1">Experience conducting or supporting supplier audits and assessments. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1">Working knowledge of product development, design transfer, and supplier readiness activities. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1">Ability to execute defined quality processes, manage multiple priorities, and escalate issues appropriately. </li> </ul>   Certificates, Licenses, Registrations   <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" 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="19" 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">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="19" 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">Standard work hours are Monday through Friday, 9 AM to 5 PM EST. </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="19" 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">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">$84,871—$93,166 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 $170k/yr (range $1.8k–1000k/yr, n=883 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

$84.9k–93.2k/yr

Job Type

full time

Location

Remote · US East hours

~0h overlap with Jakarta hours

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Frequently asked questions

Is Quality Engineer at GeneDx a remote job?: Yes, 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 Quality Engineer at GeneDx?: The listed pay range for this role is $84.9k–93.2k/yr.
What type of employment is 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.