Senior Quality Engineer
Bantu GeneDx memastikan kualitas produk IVD dan software melalui pengembangan
Senior Quality Engineer di GeneDx bertanggung jawab untuk mengembangkan, menerapkan, dan memelihara proses QMS untuk produk IVD dan software-enabled IVD. Anda akan bekerja sama dengan tim kualitas senior untuk memastikan bahwa aktivitas dan dokumentasi teknis memenuhi standar QMS, regulasi, dan standar yang ditetapkan. Anda akan menjadi perwakilan kualitas dalam tim inti produk yang ditugaskan.
Kenapa Menarik?
Bekerja dengan tim kualitas senior dan memastikan produk memenuhi standar kualitas tinggi
Tanggung Jawab Utama
- Mengoperasikan dan memelihara proses lifecycle sesuai dengan standar yang ditetapkan
- Memberikan review dan bimbingan kualitas untuk memastikan aktivitas memenuhi standar QMS
- Bekerja sama dengan tim inti produk untuk memastikan dokumentasi teknis memenuhi standar
- Melakukan aktivitas pengembangan QMS dan produk IVD yang ditugaskan
Persyaratan
- Pengalaman dalam pengembangan QMS untuk produk IVD dan software-enabled IVD
- Pemahaman mendalam tentang standar kualitas dan regulasi
- Kemampuan untuk bekerja sama dengan tim inti produk
- Pengalaman dalam review dan bimbingan kualitas
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> <p><span data-contrast="auto">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</span><span data-contrast="auto"> senior members of the IVD Quality team.</span><span data-ccp-props="{"335559739":0}"> </span></p> <p><span data-contrast="auto">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. </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559737":0,"335559738":0,"335559739":0,"335559740":259}"> </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="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"><span data-contrast="auto">Execute assigned IVD QMS and product-development activities, ensuring that lifecycle processes are operationalized and maintained in compliance with established standards.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">Draft, revise, route for review and approval, and maintain SOPs, work instructions, forms, templates, and other controlled quality-system documentation.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">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.</span><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}"> </span></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"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">Compile and analyze assigned Quality metrics and prepare inputs for Quality-governance and management-review activities.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">Identify process gaps, compliance risks, and improvement opportunities; recommend and help implement practical, risk-based solutions.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">Support supplier-quality activities as assigned, including supplier documentation, design-transfer readiness, supplier change assessments, and supplier corrective-action follow-up. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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"><span data-contrast="auto">Promote a culture of quality, accountability, continuous improvement, and cross-functional collaboration.</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><span data-contrast="auto">A bachelor’s or advanced degree in a scientific, engineering, technical, or related discipline (e.g., Biology, Chemistry, Biomedical Engineering, Medical Technology).</span></li> <li><span data-contrast="auto">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. </span></li> <li><span data-contrast="auto">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.</span></li> <li><span data-contrast="auto">Expertise in technical writing and QMS development; demonstrated experience drafting, revising, and implementing Standard Operating Procedures (SOPs), work instructions, and quality templates. </span></li> <li><span data-contrast="auto">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.</span></li> <li><span data-contrast="auto">Experience using Ketryx or similar connected lifecycle management and automated compliance tools for traceability and lifecycle management is a plus.</span></li> <li><span data-contrast="auto">Experience supporting regulatory submissions and audits/inspections. </span></li> <li><span data-contrast="auto">Ability to manage multiple projects and priorities in a fast-paced environment.</span></li> </ul> <p><span data-ccp-props="{"201341983":0,"335559685":720,"335559739":0,"335559740":240,"335559991":360,"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="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"><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}"> </span></li> </ul> <p><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></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="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"><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="{"335559685":720}"> </span></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"><span data-contrast="auto">Standard work hours are Monday through Friday, 9 AM to 5 PM EST.</span><span data-ccp-props="{"335559685":720}"> </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>$131,037</span><span class="divider">—</span><span>$145,147 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 $195k/yr (kisaran $13.4k–450k/yr, dari 404 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 Senior Quality Engineer di GeneDx bisa dikerjakan remote?
- Ya, Senior 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 Senior Quality Engineer di GeneDx?
- Rentang gaji yang tercantum untuk posisi ini adalah $131k–145.1k/yr.
- Jenis pekerjaan apa Senior 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.
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