{"id":1513025,"url":"https://alion.io/job/livanova-quality-engineer-on-site","title":"Quality Engineer (On-site)","company":{"id":1949485,"name":"LivaNova","domain":"livanova.com","url":"https://alion.io/company/livanova","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":8,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-14T06:34:16Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Denver, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":75000,"max":null,"currency":"USD","period":"year","gross":null,"usd_annual":75000},"salary_estimate":null,"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"Ignite","optional":false},{"name":"PyTorch","optional":true}],"status":"live","first_seen_at":"2026-04-10T00:00:00Z","employer_posted_date":"2026-04-10","last_verified_at":"2026-10-13T19:09:53Z","board_verified":true,"closed_at":null,"days_open":187,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":187},"description":"As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow-because at LivaNova, we don’t just treat conditions - we aspire to alter the course of lives.\nPosition Summary:\nWith a high degree of autonomy, person will perform quality work of a broad nature to achieve successful outcomes of departmental and company objectives.\nThe Quality Engineer will contribute to ensure that production and process control activities are conducted in compliance with the company quality management system and the international regulations governing medical device manufacturing and distribution.\nHe/she evaluates situations of non-conforming products, collects and analyses data to propose product disposition and CAPA's to address quality issues. This position also analyzes product complaint returns and determines actions required to prevent recurrence or communicates the information to the manufacturer or creates process improvements.\nThis is an on-site position located at our office in Arvada, CO.\nGeneral Responsibilities:\nHe/she supports Quality Management for executing the quality engineering activities related to the design and manufacture of the products in compliance with the Quality Management System requirements and the regulations of the countries where the franchise distributes and sells products.\n1. With respect to Nonconforming product handling, He/She will:\nCollect and critically analyze data and take disposition decisions on nonconforming products identified in production.\n\nLead proper investigation to identify the causes of components / product failures (nonconforming products from production and complaints)\n\nGenerate the evaluation of the risk posed by the observed NC on products already distributed (Health Hazard Evaluation) to help management determine if Stop Shipment and/or Field Action is initiated.\n\nLead CAPA projects and trend data to identify opportunities for future CAPA.\n\nWhenever applicable support external manufacturers of semi-finished and finished products in the management of any detected nonconformities.\n\nMay notify suppliers of any non-conformance related to purchased material and evaluate corrective actions consistency versus internal controls.\n\nWith respect to the Design Control & Production and Process control, He/She will:\n\nEstablishes product quality control inspections/plans\n\nReviews process validation planning, protocols and reports\n\nPerform preliminary review of the change impact assessment to confirm that quality requirements are met\n\nEstablish and maintain Risk Management files\n\nCollaborates in the investigations into the cause of V&V failures\n\nIdentify opportunities for quality improvements in the production area and lead improvement plans\n\n2. With respect to Analysis of Complaint data and Returned Products, He/She will:\nDaily management of the assigned complaint handling activities.\n\nProviding daily support, as needed for:\n\nCustomer-related processes involving use of the device.\n\nComplaint evaluations and investigations.\n\nProvides support for timely analysis to meet Customer Quality complaint and MDR reporting quality metrics.\n\nLeads effective meetings, conducts presentations, establishes quality records.\n\nDevelops effective relationships with internal personnel and external stakeholders to assist customers and drive the resolution of customer complaints\n\nHe/She respects the Health and Safety Regulations in his/her field of competence. Performs other duties as may be required by their manager.\nSkills and Experience:\nMinimum related work experience of 1-3 years in Class II/III medical device manufacturing or related regulatory industry.\nKnowledge of regulatory requirements (e.g., FDA, ISO 13485) as required for the position.\nExperience with MDSAP and Medical Device Requirements is a plus\nMust have proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning\nAbility to analyze and problem-solve with CAPA experience\nAbility to work within a changing environment.\nAbility to work with a wide variety of personnel on all levels and utilize constructive confrontation\nASQ Certified Quality Engineer or other ASQ Certifications is a plus.\nExcellent communication (written and verbal) and presentation skills.\nAble to communicate across functional lines.\nSitting 60-80%, standing & walking 20-40%\nRepetitive work on computer 80%\nOral and written comprehension\nMust be able to work in a clean room environment and tolerate chemical odors.\nMust be able to work in a lab environment and tolerate the smell and sight of blood.\nMust be willing to take on related duties as required in support of company and departmental objectives.\nEducation:\nBachelor’s Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, and Biology)\nTravel Requirements:\nOccasional travel may be required.\nPay Transparency: A reasonable estimate of the annual base salary for this position is $75,000 + discretionary annual bonus. Pay ranges may vary by location.\nEmployee benefits include:\nHealth benefits - Medical, Dental, Vision\n\nPersonal and Vacation Time\n\nRetirement & Savings Plan (401K)\n\nEmployee Stock Purchase Plan\n\nTraining & Education Assistance\n\nBonus Referral Program\n\nService Awards\n\nEmployee Recognition Program\n\nFlexible Work Schedules\n\nWelcome to impact. Welcome to innovation. Welcome to your new life.","description_format":"text","description_chars":5778,"description_truncated":false,"requirements":{"experience_years_min":1,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Education assistance","Flexible schedule","Retirement plans"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care"],"lifecycle":[{"event":"open","at":"2026-09-30T08:35:17Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 13 · green card filings: 1","filings_12m":13,"filings_prev_12m":12,"green_card_filings_12m":1,"median_offered_wage_usd":138214,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+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":3,"band":"cold","label":"Long shot","p_open":1,"p_active":0.105,"p_room":0.28,"age_days":187,"expected_fill_days":17,"reasons":["conf:11","velocity","win:tail","crowd:junior"],"computed_at":"2026-10-14T06:34:16Z"},"pay":{"stated_usd_annual":75000,"is_top_pay":false},"html_url":"https://alion.io/job/livanova-quality-engineer-on-site","json_url":"https://alion.io/job/livanova-quality-engineer-on-site.json","meta":{"generated_at":"2026-10-14T12:41:40Z","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":15587,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-15T00:00:00Z"}},"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":1949485},"rest":"https://alion.io/mcp/rest/get_company?id=1949485"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flivanova-quality-engineer-on-site"},{"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%2Flivanova-quality-engineer-on-site"},{"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%2Flivanova-quality-engineer-on-site"},{"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/livanova-quality-engineer-on-site\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flivanova-quality-engineer-on-site"}]}