{"id":2750838,"url":"https://alion.io/job/caris-life-sciences-design-quality-engineer","title":"Design Quality Engineer","company":{"id":1953796,"name":"Caris Life Sciences","domain":"carislifesciences.com","url":"https://alion.io/company/carislifesciences","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":91,"open_postings":8,"ghost_share":0,"stale_share":0.375,"repost_share":0,"time_to_fill_p50_days":40,"computed_at":"2026-10-19T05:45:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Tempe, United States","Irving, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":65000,"max_usd":153000,"period":"year","method":"role_country_seniority_unknown","sample_n":13313},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-16T23:56:38Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-19T00:13:05Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care-we’re changing lives.\nWe introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day:“What would I do if this patient were my mom?”That question drives everything we do.\nBut our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose.\nJoin us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.\nPosition Summary\nThe Design Quality Engineer is responsible for authoring Quality deliverables, reviewing, maintaining the Design history file (DHF) and Risk File records, ensuring compliance with all applicable regulations. The position will work in collaboration with the Development, Laboratory Operations, Regulatory Affairs, project/program management, and other cross-functional teams throughout the product lifecycle activities supporting vitro diagnostics (IVDs) and Laboratory Developed Tests (LDTs), at Caris Life Sciences.\nJob Responsibilities\nSupport New Product development, design changes and post launch activities as the Quality representative on sustaining projects.\nCreate Technical records, review and approve Design History File\nCreate and maintain the Risk Management records in alignment with quality system and regulatory requirements including design and use risk assessments.\nPerform Risk assessment for the Quality Events, Nonconformance and complaints.\nAble to work independently with minimal supervision.\nCan plan and coordinate work according to the project schedule.\nSupport inspection readiness by providing risk management /DHF documentation and creating quality plan as needed.\nSupport design changes to assess and document risk impact of product and process changes.\nRequired Qualifications\nBachelor’s degree in scientific, engineering or related field with 0-4 years of experience in product development, IVD, diagnostics, biotech, or clinical laboratory environments.\nWorking knowledge of product development processes.\nUnderstanding of ISO 13485 quality management system requirements.\nPreferred Qualifications\nDesign controls experience, including DHF, traceability matrices, V&V documentation, and design review records is a plus.\nExperience with medical device risk management (ISO 14971)\nWorking knowledge of ISO 15189 and ISO 22367 requirements\nAbility to adapt to a fast-paced, dynamic work environment with shifting priorities.\nExperience supporting oncology diagnostic development, LDT workflows, or molecular assay development.\nPhysical Demands\nAbility to lift routine office supplies and use standard office equipment.\nAbility to sit for extended periods of time.\nMajority of work performed in a desk or cubicle environment, with occasional exposure to laboratory environments including noise, fumes, and bio-hazardous materials.\nTraining\nAll job specific, safety, and compliance training are assigned based on the job functions associated with this employee.\nOther\nTravel- 10% may be required\nConditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check( applicable for certain positions) and reference verification.\nThis job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.\nCaris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.","description_format":"text","description_chars":4179,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Molecular Diagnostics","Genomics & Genetic Testing","Precision Medicine"],"lifecycle":[{"event":"open","at":"2026-10-16T23:56:38Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":40,"reasons":["conf:5","win:early"],"computed_at":"2026-10-19T05:45:15Z"},"pay":null,"html_url":"https://alion.io/job/caris-life-sciences-design-quality-engineer","json_url":"https://alion.io/job/caris-life-sciences-design-quality-engineer.json","meta":{"generated_at":"2026-10-19T11:30:27Z","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":8116,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-20T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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":1953796},"rest":"https://alion.io/mcp/rest/get_company?id=1953796"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcaris-life-sciences-design-quality-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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%2Fcaris-life-sciences-design-quality-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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%2Fcaris-life-sciences-design-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/caris-life-sciences-design-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcaris-life-sciences-design-quality-engineer"}]}