{"id":457975,"url":"https://alion.io/job/foundation-medicine-senior-quality-engineer","title":"Senior Quality Engineer","company":{"id":176045,"name":"Foundation Medicine","domain":"foundationmedicine.com","url":"https://alion.io/company/foundation-medicine","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":{"grade":"A","score":90,"open_postings":5,"ghost_share":0,"stale_share":0.4,"repost_share":0,"time_to_fill_p50_days":58,"computed_at":"2026-10-27T05:46:45Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Boston, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":101200,"max":126500,"currency":"USD","period":"year","gross":null,"usd_annual":126500},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Veeva","optional":false},{"name":"21 CFR Part 11","optional":true},{"name":"HIPAA","optional":true},{"name":"ISO 13485","optional":true}],"status":"live","first_seen_at":"2026-07-29T20:55:09Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-27T04:42:41Z","board_verified":true,"closed_at":null,"days_open":89,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":89},"description":"About the Job:\nThe Senior Quality Engineer is responsible for governance, optimization, lifecycle support, and continuous improvement of Foundation Medicine's electronic Quality Management System (eQMS), including Veeva Vault Quality. The role serves as a Quality Systems subject matter expert, partnering with Quality process owners, IT, Product, and business stakeholders to ensure compliant, scalable, and effective digital quality operations. The position supports Quality Systems processes including CAPA, nonconformance, change control, document control, training, audit management, risk management, and Management Review.\nRegular onsite work at a designated FMI location is an essential function of this role.\nThe Senior Quality Engineer - Digital Quality Systems & eQMS will play a critical role in governing, optimizing, and advancing Foundation Medicine’s electronic Quality Management System (eQMS), including Veeva Vault Quality. As a key Quality Systems subject matter expert, this role partners across Quality, Technology, Product, and business functions to ensure compliant, efficient, and scalable digital quality operations. The position supports and enhances core quality processes -including CAPA, nonconformance, change control, document control, training, audit management, risk management, and Management Review - while driving system improvements, data-driven insights, and continuous process optimization. Through a combination of technical expertise, quality systems knowledge, and cross-functional collaboration, the Senior Quality Engineer helps strengthen inspection readiness, advance digital transformation initiatives, and support Foundation Medicine’s mission of delivering high-quality products and services that improve patient outcomes.\nKey Responsibilities:\nEQMS Governance & Digital Quality Systems\nServe as Quality business lead and SME for Veeva Vault Quality\nProvide governance and lifecycle support for the eQMS\nPartner with Technology, Digital Solutions, vendors, and process owners\nTranslate compliance and process requirements into system requirements\nSupport UAT, CSA/CSV, validation, deployment readiness and change impact assessments\nMaintain system documentation and validation records\nSupport integrations between enterprise systems\n\nQuality System Process Enablement\nSupport CAPA, nonconformance, change control, document control, training, audit management, risk management, and Management Review.\nDevelop procedures, work instructions, training materials, and governance documentation.\nSupport issue investigation and resolution related to eQMS processes.\nSupport Quality Improvement Plans.\nSupport regulatory inspections and audits through retrieval of records and evidence.\n\nMetrics and Continuous Improvement\nDevelop dashboards and metrics.\nSupport Quality Management Review.\nAnalyze trends and recommend improvements.\nDrive digital quality system adoption and process optimization.\nAssist with reporting Key Performance Indictors (KPIs).\nPerform periodic trending of CAPAs to identify systemic issues, Action plan approvals, Action Task due dates, and root cause failure modes.\nBe responsible for compliance with applicable Corporate and Divisional Policies and procedures.\nOther duties as assigned.\nComply with FMI's attendance policies\n\nQualifications:\nBasic Qualifications:\nBachelor's degree in Quality, Life Sciences, Computer Systems, Information Systems, Operations or equivalent years of experience in technical or engineering discipline\n5+ years of related professional experience in Quality Assurance, Quality Systems, eQMS administrative support or a related regulated environment\nPreferred Qualifications:\n5+ years of related professional experience in Quality Assurance, Quality Systems, eQMS administrative support or a related regulated environment\nExperience supporting electronic Quality Management Systems including governance, validation, reporting, lifecycle management or configuration support\nVeeva Vault Quality experience preferred.\nExperience with MasterControl, TrackWise, or equivalent eQMS platforms.\nExperience with system implementation, validation, release management, and integrations.\nKnowledge of CSA/CSV and 21 CFR Part 11.\nDashboard and metric reporting experience.\nLean Six Sigma and ASQ certifications.\nExperience operating under FDA QMSR, ISO 13485, ISO 15189, CLIA, CAP, and GxP environments.\nKnowledge of Root Cause Analysis\nDemonstrated Technical Writing Skills/Training\nUnderstanding of HIPAA and the importance of patient data privacy\nCommitment to reflect FMI’s values: Integrity, Courage, and Passion\nThe expected salary range for this position based on the primary location of Boston, MA is $101,200 - $126,500 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.\n#LI-Hybrid","description_format":"text","description_chars":5126,"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":["Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Genomics & Genetic Testing","Precision Medicine","Medical Laboratories"],"lifecycle":[{"event":"open","at":"2026-09-06T10:10:46Z"},{"event":"close","at":"2026-10-06T04:08:48Z"},{"event":"reopen","at":"2026-10-06T19:58:53Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 26 · green card filings: 11","filings_12m":26,"filings_prev_12m":23,"green_card_filings_12m":11,"median_offered_wage_usd":136959,"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)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":27,"band":"fade","label":"Fading","p_open":1,"p_active":0.75,"p_room":0.36,"age_days":89,"expected_fill_days":58,"reasons":["conf:1","velocity","win:tail","crowd:"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":126500,"is_top_pay":false},"html_url":"https://alion.io/job/foundation-medicine-senior-quality-engineer","json_url":"https://alion.io/job/foundation-medicine-senior-quality-engineer.json","meta":{"generated_at":"2026-10-27T10:52:03Z","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":12727,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":176045},"rest":"https://alion.io/mcp/rest/get_company?id=176045"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ffoundation-medicine-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%2Ffoundation-medicine-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%2Ffoundation-medicine-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/foundation-medicine-senior-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ffoundation-medicine-senior-quality-engineer"}]}