{"id":2846222,"url":"https://alion.io/job/edwards-lifesciences-senior-engineer-quality-2","title":"Senior Engineer, Quality","company":{"id":5220,"name":"Edwards Lifesciences","domain":"edwards.com","url":"https://alion.io/company/edwards","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":50,"ghost_share":0.02,"stale_share":0.76,"repost_share":0.06,"time_to_fill_p50_days":28,"computed_at":"2026-10-27T05:46:45Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Irvine, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":108000,"max":153000,"currency":"USD","period":"year","gross":null,"usd_annual":153000},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Minitab","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-10-01T00:00:00Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-27T04:05:21Z","board_verified":true,"closed_at":null,"days_open":26,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":26},"description":"Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Engineer, Quality position is a unique career opportunity that could be your next step towards an exciting future.\nImagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.\nAs a Manufacturing Sustaining Senior Quality Engineer supporting 1st shift Irvine Implant Manufacturing operations, this role applies quality engineering principles to maintain compliant manufacturing processes, resolve complex product quality and compliance issues, support risk management activities, and drive continuous improvement in a regulated medical device environment.\nHow you’ll make an impact:\nInvestigate complex manufacturing product quality and compliance issues reported internally and/or from the field, analyze results, determine root causes, and initiate and review reports (e.g., Non-Conformances, CAPA, Audit resolutions).\nExercise independent judgment in owning complex quality investigations, leading cross-functional teams to align on root cause, risk impact, containment, and corrective actions, and driving systemic actions that prevent recurrence.\nDevelop, update, and maintain the technical content of risk management files and procedures.\nLead technical studies and author technical reports. Apply statistical techniques to determine appropriate sample sizes and confidence levels.\nOptimize complex manufacturing processes using quality engineering methods (e.g., Six Sigma and Lean) to drive design for manufacturing and continuous process improvement.\nTrain, coach, and guide peers and junior employees.\nWhat you’ll need (Required):\nBachelor's degree in Engineering or Scientific field with a minimum of 4 years relevant experience in Quality Engineering, Product & Process Engineering, Quality Systems, or Manufacturing; OR\nMaster’s degree in Engineering or Scientific field with 3 years of experience.\nWhat else we look for (Preferred):\nGDP and GMP proficiency and experience working in medical device, pharma, or biotech industry.\nStrong problem-solving, organizational, analytical, strict attention to detail, and critical-thinking skills.\nSolid leadership skills and the ability to influence change.\nUnderstanding of manufacturing, quality, and risk management standards.\nFDA Quality System Regulation / 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR awareness.\nExperience working with inspection and measurement tools & equipment (e.g. microscope, TAPPI, burst tester, tensile tester).\nNonconformance and CAPA management experience utilizing investigation tools for root cause analysis (e.g. Five Whys Analysis, Fishbone diagram, Flow Chart/Process Mapping).\nWorking knowledge of statistical data analysis and SPC (Minitab proficiency).\nProcess / Equipment qualification & validation experience (Test method validation, IQ/OQ/PQ, Tool and fixture IQ).\nExpertise in usage of MS Office Suite and experience using digital productivity tools and AI-enabled applications.\nAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.\nFor California, the base pay range for this position is $108,000 - $153,000 (highly experienced). \nThe pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.\nEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.","description_format":"text","description_chars":4353,"description_truncated":false,"requirements":{"experience_years_min":4,"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":["Cardiovascular Devices","Patient Monitoring"],"lifecycle":[{"event":"open","at":"2026-10-19T11:08:31Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 45 · green card filings: 24","filings_12m":45,"filings_prev_12m":77,"green_card_filings_12m":24,"median_offered_wage_usd":125978,"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":43,"band":"fade","label":"Fading","p_open":1,"p_active":0.573,"p_room":0.75,"age_days":26,"expected_fill_days":28,"reasons":["conf:1","stale_co","velocity","win:late","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":153000,"is_top_pay":true},"html_url":"https://alion.io/job/edwards-lifesciences-senior-engineer-quality-2","json_url":"https://alion.io/job/edwards-lifesciences-senior-engineer-quality-2.json","meta":{"generated_at":"2026-10-27T06:54:32Z","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":7182,"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":5220},"rest":"https://alion.io/mcp/rest/get_company?id=5220"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fedwards-lifesciences-senior-engineer-quality-2"},{"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%2Fedwards-lifesciences-senior-engineer-quality-2"},{"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%2Fedwards-lifesciences-senior-engineer-quality-2"},{"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/edwards-lifesciences-senior-engineer-quality-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fedwards-lifesciences-senior-engineer-quality-2"}]}