{"id":2505740,"url":"https://alion.io/job/element-science-senior-quality-engineer","title":"Senior Quality Engineer","company":{"id":2057833,"name":"Element Science","domain":"elementscience.com","url":"https://alion.io/company/elementscience","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Redwood City, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":104000,"max":132000,"currency":"USD","period":"year","gross":null,"usd_annual":132000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"IEC 60601","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Statistical Process Control","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-01T17:25:10Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-10-23T02:57:27Z","board_verified":true,"closed_at":null,"days_open":21,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":21},"description":"Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery. \nWe are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience-designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Cormorant Asset Management, and Invus Opportunities.\nSUMMARY OF ROLE:\nElement Science is seeking a Sr. Quality Engineer to support the ongoing quality, reliability, and continuous improvement of our life-saving medical device technology. This role provides Quality Engineering support across the commercial product life cycle and leads the supplier quality program. It partners closely with Engineering, Manufacturing, Supplier Quality, Operations, Supply Chain and other cross-functional teams to ensure products and purchased components continue to meet quality, safety, performance, and regulatory requirements throughout the commercial product lifecycle.\nThe Sr. Quality Engineer will provide Quality Engineering support for product and process changes, nonconformances, CAPAs, complaints, supplier qualification and performance, risk management, and verification and validation activities. This role will partner with manufacturing on process capability and provide Quality oversight and approval to those activities.The ideal candidate brings strong technical problem-solving skills, sound quality judgment, and a collaborative, hands-on approach to identifying root causes and driving sustainable improvements.\nRESPONSIBILITIES:\nSustaining Quality\nServe as the Quality Engineering partner for sustaining engineering and post-market product activities, ensuring continued compliance with applicable quality and regulatory requirements.\nProvide Quality oversight for product, component, manufacturing, supplier, and design changes, including assessment of verification and validation requirements.\nSupport nonconformance, complaint investigation and CAPA activities, including root cause analysis, risk assessment, corrective actions, and effectiveness verification.\nPartner with Engineering and Operations to investigate product and manufacturing issues and implement sustainable corrective and preventive solutions.\nMaintain and update Risk Management Files in accordance with ISO 14971, incorporating post-market information, product changes, complaints, and identified risks.\nAnalyze quality and product performance metrics to identify trends and drive systemic quality and reliability improvements.\nProvide technical Quality expertise for electrical and electromechanical product issues and changes.\nSupplier Quality\nResponsible for supplier quality programs including supplier evaluation, selection, qualification, re-qualification and maintenance of the Approved Supplier List (ASL).\nPlan and perform onsite and remote supplier audits to assess compliance with ISO 13485, regulatory standards, and internal requirements. \nEstablish and maintain supplier quality agreements.\nMonitor supplier quality performance through scorecards and periodic quality reviews, including Supplier Corrective Action Requests (SCARs) and drive them to closure\nDefine incoming inspection requirements, sampling plans, and first article inspection for purchased components. Lead disposition of supplier-related nonconformances through MRB.\nReview supplier process capability and validation evidence for critical-to-quality characteristics during supplier qualification and change approval.\n Lead supplier quality improvement initiatives.\nManufacturing & Process Quality Oversight\nPartner with Manufacturing Engineering on process characterization, process capability (Cpk/Ppk), SPC, pFMEA, and process and equipment validation (IQ/OQ/PQ). Review and approve protocols and reports ensuring acceptance criteria are risk-based and statistically justified.\n Develop and execute verification and validation plans, protocols, and reports for sustaining activities, including test method validation for inspection and test methods, as applicable.\nQuality System & Leadership\nSupport continuous improvement of Quality System procedures, Standard Operating Procedures, and Work Instructions.\n Mentor junior engineers and Quality team members, and promote strong Quality Engineering practices across cross-functional teams.\nPerform other responsibilities as assigned.\nQUALIFICATIONS:\n5+ years of Quality Engineering or Sustaining Engineering experience within the medical device industry, preferably supporting commercial electromechanical products.\nDemonstrated experience with post-market and sustaining quality activities, including nonconformances, CAPAs, change control, root cause investigations, and verification and validation.\nWorking knowledge of ISO 13485, FDA Quality System requirements, ISO 14971, and IEC 60601-1.\nExperience applying risk management principles throughout the commercial product lifecycle.\nStrong technical problem-solving and root cause analysis skills.\nBachelor’s degree in Engineering, Science, or a related technical discipline; Master’s degree is a plus.\nAbility to work effectively across Engineering, Manufacturing, Operations, Supplier Quality, and other cross-functional teams.\nStrong organizational skills with the ability to manage multiple priorities and consistently complete work on schedule.\nExcellent written and verbal communication skills.\nBENEFITS:\nElement Science offers a very competitive salary and benefits package including, but not limited to:\nStock Options\n90% employer-paid medical, dental, and vision insurance\nCompany-paid Basic Life Insurance\n401(k) retirement plan (Traditional and Roth)\nCompetitive Paid Time Off\nPaid Holidays\nFSA (Flexible Spending Accounts)\nHSA (Health Savings Account)\nEmployee Assistance Program through PEO\nThe salary for this exempt-level position will be based on experience and qualifications within an established pay range.\nPay range: $104,000 - $132,000\nElement Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law. \nIn compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job. \nAt this time, we are unable to offer relocation assistance at Element Science.","description_format":"text","description_chars":7739,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Life insurance","Relocation assistance","Retirement plans","Stock options","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Cardiovascular Devices"],"lifecycle":[{"event":"open","at":"2026-10-14T07:14:55Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":1,"green_card_filings_12m":0,"median_offered_wage_usd":202500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":75,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.831,"p_room":0.9,"age_days":20,"expected_fill_days":42,"reasons":["conf:2","win:mid"],"computed_at":"2026-10-22T06:10:10Z"},"pay":{"stated_usd_annual":132000,"is_top_pay":false},"html_url":"https://alion.io/job/element-science-senior-quality-engineer","json_url":"https://alion.io/job/element-science-senior-quality-engineer.json","meta":{"generated_at":"2026-10-23T05:42:44Z","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":9307,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"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":2057833},"rest":"https://alion.io/mcp/rest/get_company?id=2057833"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Felement-science-senior-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%2Felement-science-senior-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%2Felement-science-senior-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/element-science-senior-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Felement-science-senior-quality-engineer"}]}