{"id":4287965,"url":"https://alion.io/job/genedx-software-quality-engineer","title":"Software Quality Engineer","company":{"id":1702,"name":"GeneDx","domain":"genedx.com","url":"https://alion.io/company/genedx","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"QA","role_family":"QA","seniority":"senior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"inferred_payroll_markers","remote_working_hours":{"label":"EST","utc_offset_min":-5,"utc_offset_max":-5},"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":["US","CA"],"hiring_countries_total":2,"salary":{"min":111249,"max":122620,"currency":"USD","period":"year","gross":null,"usd_annual":122620},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-09-02T16:36:39Z","employer_posted_date":"2026-11-13","last_verified_at":"2026-11-13T22:28:32Z","board_verified":true,"closed_at":null,"days_open":72,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":72},"description":"Summary \nThe Software Quality Engineer, IVD Quality supports the development, implementation, and maintenance of software-specific QMS processes, including Software Development Life Cycle (SDLC), Software Risk Management, and Cybersecurity, for GeneDx’s IVD and digital products. The role reports to the Director, IVD Regulatory and Quality and works in close partnership with senior members of the IVD Quality team. \nServing as the Quality representative on software development and bioinformatics teams, the Software Quality Engineer provides Quality review, guidance, and process support to ensure that software engineering activities and supporting technical documentation meet established QMS, regulatory, and standards requirements (e.g., IEC 62304 and ISO 62366). \nJob Responsibilities \nExecute assigned software-development Quality activities and support the build-out of associated SDLC QMS processes. \nProvide Quality review and process oversight for software design-control activities, including software requirements, architecture documentation, code-review records, and verification and validation documentation, to support compliance and audit readiness. \nParticipate in the development and review of Design and Development File documentation throughout the product lifecycle. \nServe as the Quality representative for software risk-management activities, providing guidance and review throughout the software lifecycle. \nProvide Quality support for validation of non-product software tools used in operations, product testing, and the quality system. \nSupport the investigation and resolution of software-related nonconformances, deviations, and CAPAs. \nProvide Quality input on cybersecurity-related design-control, risk-management, vulnerability-management, and post-market activities to support alignment with applicable FDA cybersecurity guidance and established QMS requirements. \nSupport internal and external audits by preparing software-related objective evidence and assisting with responses to findings. \nMonitor evolving regulatory expectations, standards, and best practices for software in IVDs, including FDA and international guidance; recommend updates to applicable processes and documentation. \nContribute to continuous improvement initiatives related to software development and quality processes. \nEducation, Experience, and Skills \nA bachelor’s or advanced degree in a relevant scientific or technical field (e.g., Computer Science, Engineering, Bioinformatics).\n6+ years of software QA experience, with 4+ years in medical device or FDA-regulated software development. \nPractical experience with design controls, ISO 13485, ISO 14971, IEC 62304 regulations.\nExperience with Software as a Medical Device or medical devices containing software. Strong understanding of design control procedures and the software development lifecycle in regulated environments. \nExperience supporting regulatory submissions and audits. \nAbility to manage multiple projects and priorities in a fast-paced environment.\nCertificates, Licenses, Registrations \nCertified Software Quality Engineer (CSQE) preferred. \nWork Environment \nThis 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. \nStandard work hours are Monday through Friday, 9 AM to 5 PM EST. \nPay Transparency, Budgeted Range\n$111,249—$122,620 USD\nA culture that plays to win, because patients are counting on us\nAt 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.\nHere’s what you can expect day to day:\n1. Play like a champion (step up, redefine what’s possible, own it)\nWe bring energy, focus, and a bias for action. We step up, take initiative, and deliver on our commitments - with quality, speed, and care.\n2. Think bigger (stretch beyond, courage not consensus)\nWe push past the obvious. We challenge assumptions, raise the bar, and make thoughtful, decisive calls - choosing progress over perfection.\n3. Grow fast (be curious, speak up, be agile)\nWe stay curious, ask questions, and share direct feedback with respect. We adapt quickly and keep learning through collaboration and continuous improvement.\nIf you’re motivated by meaningful work, a fast-moving environment, and teammates who care deeply about outcomes, you’ll thrive at GeneDx.\nAt 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.\nWe 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.\nGeneDx is a place where people from all backgrounds can make an impact.\n\n All privacy policy information can be found here.","description_format":"text","description_chars":5671,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Home office"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"},{"name":"Canada","iso":"CA","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Molecular Diagnostics","Information Security"],"lifecycle":[{"event":"open","at":"2026-11-13T22:28:32Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 1 · green card filings: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":1,"median_offered_wage_usd":162500,"route":null,"cap_exempt":false,"checked_at":"2026-11-12T07:36:15+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":29,"band":"fade","label":"Fading","p_open":1,"p_active":0.803,"p_room":0.36,"age_days":72,"expected_fill_days":41,"reasons":["conf:1","win:tail","crowd:"],"computed_at":"2026-11-14T00:00:09Z"},"pay":{"stated_usd_annual":122620,"is_top_pay":true},"html_url":"https://alion.io/job/genedx-software-quality-engineer","json_url":"https://alion.io/job/genedx-software-quality-engineer.json","meta":{"generated_at":"2026-11-14T00:00:09Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":4,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-15T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1702},"rest":"https://alion.io/mcp/rest/get_company?id=1702"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgenedx-software-quality-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fgenedx-software-quality-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fgenedx-software-quality-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/genedx-software-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgenedx-software-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4287965}},{"tool":"search_jobs","arguments":{"company":"genedx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4287965},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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