Quality Engineer
Bantu GeneDx memastikan kualitas produk IVD dan perangkat lunak
Quality Engineer di GeneDx bertanggung jawab untuk mengimplementasikan, memelihara, dan mengeksekusi proses kualitas supplier dan pasca-pemasaran untuk produk IVD dan perangkat lunak IVD. Anda akan bekerja sama dengan tim kualitas IVD senior dan melaporkan kepada Direktur, IVD Regulatory dan Quality. Fokus awal adalah pada kualitas supplier, termasuk kualitas supplier, pemantauan, manajemen perubahan, pemantauan kinerja, dan investigasi terkait s
Kenapa Menarik?
Anda akan bekerja dengan tim senior dan mempengaruhi kualitas produk GeneDx
Tanggung Jawab Utama
- Melakukan kualifikasi dan pemantauan supplier
- Mengelola perubahan dan kinerja supplier
- Melakukan investigasi terkait supplier
- Menangani keluhan pasca-pemasaran
- Mengelola nonkonformitas dan deviasi
- Mendukung CAPA dan laporan tren kualitas
Persyaratan
- Pengalaman dalam kualitas IVD dan perangkat lunak IVD
- Kemampuan untuk bekerja sama dengan tim senior
- Pengalaman dalam manajemen perubahan dan pemantauan kinerja
- Kemampuan untuk menangani keluhan dan investigasi
Skills Wajib
Konteks Indonesia
- Overlap Jam Kerja:
- Overlap minimal — jam kerja berlawanan
Lihat Deskripsi Asli dari Greenhouse BoardsTampilkan selengkapnya
Deskripsi asli dari Greenhouse Boards
<p><strong><span data-contrast="auto">Summary </span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <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"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <p><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto">Job Responsibilities</span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <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"><span data-contrast="auto">Support implementation, maintenance, and continuous improvement of established IVD supplier-quality and post-market quality processes.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">Conduct or support supplier audits and assessments; prepare audit reports and track supplier corrective actions to closure.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">Support supplier readiness during design transfer by confirming supplier qualification status, required documentation, and applicable process controls.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">Execute assigned post-market quality activities, including complaint intake and investigation support, nonconformances, deviations, CAPAs, quality-event documentation, action tracking, and effectiveness checks.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">Compile supplier and post-market quality metrics and support trend reporting, management review, and quality-governance activities.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">Draft and maintain supplier-quality and post-market quality procedures, work instructions, forms, templates, and quality records, following established QMS standards.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">Support audit and inspection readiness by organizing objective evidence and responding to requests under the direction of Quality leadership.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">Identify process gaps and improvement opportunities within assigned processes and escalate recommendations for broader QMS changes.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ul> <p><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><strong><span data-contrast="auto">Education, Experience, and Skills</span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <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"><span data-contrast="auto">Bachelor’s degree in a scientific, engineering, technical, or related discipline.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></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"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></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"><span data-contrast="auto">Experience with supplier qualification, supplier monitoring, quality agreements, supplier corrective actions, supplier change assessments, and supplier performance monitoring.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></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"><span data-contrast="auto">Experience supporting at least one post-market quality process, such as complaint handling, nonconformance management, deviation management, CAPA, investigations, or quality trending.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></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"><span data-contrast="auto">Working knowledge of applicable FDA quality-system requirements, ISO 13485, and ISO 14971.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></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"><span data-contrast="auto">Experience conducting or supporting supplier audits and assessments.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></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"><span data-contrast="auto">Working knowledge of product development, design transfer, and supplier readiness activities.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></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"><span data-contrast="auto">Ability to execute defined quality processes, manage multiple priorities, and escalate issues appropriately.</span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <p><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></p> <p><strong><span data-contrast="auto">Certificates, Licenses, Registrations </span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <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"><span data-contrast="auto">ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Internal Auditor, and/or ISO 13485 Lead Auditor certification preferred. </span><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240,"469777462":[720],"469777927":[0],"469777928":[1]}"> </span></li> </ul> <p> </p> <p><strong><span data-contrast="auto">Work Environment </span></strong><span data-ccp-props="{}"> </span></p> <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"><span data-contrast="auto">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.</span><span data-ccp-props="{}"> </span></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"><span data-contrast="auto">Standard work hours are Monday through Friday, 9 AM to 5 PM EST.</span><span data-ccp-props="{}"> </span></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"><span data-contrast="auto">Ability to travel up to 20% of the time, including occasional domestic and international travel, to conduct supplier audits and support supplier qualification activities.</span><span data-ccp-props="{}"> </span></li> </ul> <p><br><span style="color: rgb(236, 240, 241);">#LI-REMOTE</span></p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Pay Transparency, Budgeted Range</div><div class="pay-range"><span>$84,871</span><span class="divider">—</span><span>$93,166 USD</span></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"> <p>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.<br><br><strong>Here’s what you can expect day to day:</strong><br><br>1. Play like a champion (step up, redefine what’s possible, own it)</p> <p class="text-l">We bring energy, focus, and a bias for action. We step up, take initiative, and deliver on our commitments – with quality, speed, and care.<br><br></p> <div class="card-number">2. Think bigger (stretch beyond, courage not consensus)</div> <p class="text-l">We push past the obvious. We challenge assumptions, raise the bar, and make thoughtful, decisive calls — choosing progress over perfection.<br><br></p> <div class="card-number">3. Grow fast (be curious, speak up, be agile)</div> <p class="text-l">We stay curious, ask questions, and share direct feedback with respect. We adapt quickly and keep learning through collaboration and continuous improvement.<br><br>If you’re motivated by meaningful work, a fast-moving environment, and teammates who care deeply about outcomes, you’ll thrive at GeneDx.</p> </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> <p>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.</p> <p><strong>GeneDx is a place where people from all backgrounds can make an impact.</strong></p> <p><strong><br></strong>All privacy policy information can be found <a href="https://www.genedx.com/privacy" target="_blank">here</a>.</p></div>
Konteks Gaji
Posisi Engineering serupa di LokerDollar dibayar sekitar $170k/yr (kisaran $1.8k–1000k/yr, dari 880 listing aktif).
Pemberi kerja tidak menyatakan keterbukaan lokasi — cek langsung lowongannya
Lowongan ini menyebut jam kerja EST — cek apakah overlap-nya cocok buat kamu.
Pertanyaan yang sering diajukan
- Apakah Quality Engineer di GeneDx bisa dikerjakan remote?
- Ya, Quality Engineer di GeneDx bisa dikerjakan remote, tetapi perusahaan tidak menyebutkan negara mana saja yang boleh melamar. Cek deskripsi lowongan sebelum melamar.
- Berapa gaji untuk Quality Engineer di GeneDx?
- Rentang gaji yang tercantum untuk posisi ini adalah $84.9k–93.2k/yr.
- Jenis pekerjaan apa Quality Engineer di GeneDx?
- Posisi ini adalah pekerjaan full time.
- Bagaimana cara melamar?
- Klik tombol "Lamar" pada halaman ini untuk menuju halaman aplikasi resmi GeneDx.
Jelajahi lebih lanjut
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