{"id":1768118,"url":"https://alion.io/job/nuwellis-quality-engineer","title":"Quality Engineer","company":{"id":2015881,"name":"Nuwellis","domain":"nuwellis.com","url":"https://alion.io/company/nuwellis","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Paylocity","truth_index":null},"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":["Eden Prairie, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":81000,"max_usd":156000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4338},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-09-30T18:06:30Z","employer_posted_date":"2026-10-03","last_verified_at":"2026-10-06T19:12:50Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Description\n Nuwellis is not accepting resumes from 3rd party recruiters \n\nNuwellis is looking for a Quality Engineer to help support and strengthen our Quality Management System while ensuring our medical-device products and processes meet QMSR, ISO 13485, and other applicable regulatory requirements.\nThis role is a great fit for someone who enjoys solving problems, digging into data, working cross-functionally, and helping improve products that support patients and clinicians. You’ll partner with Engineering, Manufacturing, Supplier Quality, and Operations on quality issues, product changes, complaints, validations, supplier activities, and continuous improvement.\nWhat You’ll Do\nIn this role, you will support complaint handling, field return investigations, nonconforming material, CAPA, supplier quality, audits, validation activities, and quality documentation. You’ll help evaluate product issues, identify root cause, support corrective actions, and ensure documentation is accurate, complete, and compliant.\nYou’ll also review and approve quality documentation such as change requests, test methods, inspection criteria, specifications, and engineering records. As part of the broader quality team, you’ll support product development, process improvements, risk management, validation, supplier qualification, and internal and external audit activities.\nBecause Nuwellis has a lean quality team, this role requires someone who is comfortable working across both strategic and hands-on quality activities. The ideal candidate will be able to independently manage complex quality work while also supporting day-to-day quality tasks, documentation, inspections, and follow-up activities as needed.\nRequirements\nWhat We’re Looking For\nBachelor’s degree in engineering, science, or a related technical field; equivalent medical-device quality experience may be considered.\nAt least 5 years of quality engineering or quality assurance experience in a medical-device manufacturing or R&D environment.\nWorking knowledge of QMSR, ISO 13485, medical-device quality systems, design controls, and related standards.\nExperience with areas such as CAPA, complaints, nonconforming material, supplier quality, internal audits, risk management, product returns, or validation.\nStrong analytical, documentation, communication, and problem-solving skills.\nAbility to manage multiple priorities and work well with cross-functional teams.\nPreferred Experience\nExperience with statistical methods, process capability, quality-data analysis, validation activities, supplier quality, and electromechanical medical devices is helpful.\nWork Environment\nThis role is primarily performed in an office and manufacturing environment. It may involve sitting, standing, walking, computer work, light lifting up to 20 pounds, and use of required personal protective equipment in manufacturing, laboratory, or warehouse areas.\nNuwellis offers a comprehensive benefits package, including:\nMultiple health insurance plan options, including a high-deductible health plan with an annual company HSA contribution of $2,000 for individual coverage or $4,000 for family coverage\nCompany contribution toward dental and vision coverage\nEmployer-paid: life insurance of (up to 1X annual salary), paid short- and long-term disability\nPTO, floating holidays + 8 company holidays\n401(k) plan with a 3% company match\n Any offer of employment is contingent upon successful completion of a background check and drug screening. Nuwellis is an Equal Opportunity Employer, including minority, female, disability and veteran applicants.Salary Description\n$90,000-$110,000","description_format":"text","description_chars":3634,"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":["Health insurance","Life insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Dialysis & Kidney Care"],"lifecycle":[{"event":"open","at":"2026-10-03T14:35:46Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":5,"expected_fill_days":45,"reasons":["conf:0","win:early"],"computed_at":"2026-10-06T05:45:30Z"},"pay":null,"html_url":"https://alion.io/job/nuwellis-quality-engineer","json_url":"https://alion.io/job/nuwellis-quality-engineer.json","meta":{"generated_at":"2026-10-06T21:34:03Z","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","counted_by":"address","units_charged":1,"used_today":1123,"day_limit":5000,"remaining_today":3877,"minute_limit":60,"resets_at":"2026-10-07T00:00:00Z"}},"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":2015881},"rest":"https://alion.io/mcp/rest/get_company?id=2015881"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fnuwellis-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%2Fnuwellis-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%2Fnuwellis-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/nuwellis-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnuwellis-quality-engineer"}]}