{"id":3290952,"url":"https://alion.io/job/nuwellis-sr-quality-engineer","title":"Sr. 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":80000,"max_usd":152000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":6333},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"ISO 13485","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-26T14:13:54Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-29T13:53:32Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Description\nNuwellis is seeking a Senior Quality Engineer ready to take the next step in their career through broader responsibility, meaningful autonomy, and hands-on work improving medical devices that support patients and clinicians. As part of our lean team in Eden Prairie, Minnesota, you’ll work closely with the Director of Quality and Regulatory Affairs and cross-functional partners to solve quality challenges across new product development, manufacturing, and post-market activities.\nThis position requires regular on-site presence as an essential function of the role.\nWhat You’ll Do\nComplaint Management - Improve complaint intake and processing, conduct returned-product investigations with cross-functional partners, contribute findings to risk-management activities, and analyze complaint trends to identify opportunities for improvement.\nNew Product Development - Provide quality support for development planning, specification development, verification and validation testing, and product documentation.\nCAPA and Supplier Quality - Manage corrective and preventive action (CAPA) records, support nonconforming material handling, and participate in supplier quality activities.\nQMS Management - Review and revise procedures, support audits, and contribute to change control activities.\nManufacturing Quality Support - Help ensure manufacturing processes and resulting products meet applicable specifications and quality requirements.\nThis opportunity is well suited to a quality engineer with a solid foundation who enjoys problem-solving, data analysis, and seeing improvements through to implementation. You’ll balance hands-on quality work with broader improvement initiatives, manage competing priorities, and exercise independent judgment within your areas of responsibility. You’ll build on your existing strengths while expanding your experience across the product lifecycle, with opportunities to take on additional ownership as your experience grows.\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.\nExp erience 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\nAny offer of employment is contingent upon successful completion of a background check and drug screening.\nNuwellis is an Equal Opportunity Employer, including minority, female, disability and veteran applicants.\nNuwellis participates in the federal E-Verify program to confirm employment eligibility.\nSalary Description\n$100,000 - $120,000","description_format":"text","description_chars":3992,"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","Cardiovascular Devices"],"lifecycle":[{"event":"open","at":"2026-10-26T19:58:24Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":36,"reasons":["conf:2","win:early"],"computed_at":"2026-10-29T05:49:05Z"},"pay":null,"html_url":"https://alion.io/job/nuwellis-sr-quality-engineer","json_url":"https://alion.io/job/nuwellis-sr-quality-engineer.json","meta":{"generated_at":"2026-10-29T22:18:47Z","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":32985,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"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-sr-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-sr-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-sr-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-sr-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnuwellis-sr-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3290952}},{"tool":"search_jobs","arguments":{"company":"nuwellis.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3290952},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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