{"id":1636144,"url":"https://alion.io/job/avalign-technologies-sr-quality-engineer","title":"Sr. Quality Engineer","company":{"id":3787056,"name":"Avalign Technologies","domain":"avalign.com","url":"https://alion.io/company/avalign","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Dayforce","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Warsaw, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":89000,"max_usd":170000,"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":"2026-09-30T04:00:00Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-06T22:22:30Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"The Quality Engineer is responsible for supporting the organization to ensure quality and production goals are met. The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and ensure quality standards of all products are met.\n\nWhat You’ll Do:\nProvides quality leadership in manufacturing inspection plan development.\nProvides leadership to engineering and manufacturing functions for validation planning and NPI transfer activities. Assists teams in determining validation needs and requirements.\nProvides ongoing quality engineering support throughout the product life cycle, including CAPA investigations, and design changes. \nPrimary quality representative for site supplier management and resolution of supplier nonconformances\nSupport internal and external audits to maintain regulatory, customer and Avalign compliance.\nManages Non-Conforming Material Reports system and dispositions all non-conforming product.\nEnhances and drives product risk management activities. Ensures identified activities and mitigations are executed. \nParticipates in technical discussions and risk-based decision making.\nIdentifies opportunities and recommends improvements to quality system and manufacturing processes; drives continuous improvement. \nEstablish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.\nRecommends test methods and statistical process control procedures for achieving required levels of product reliability.\nConducts or guides testing and data analysis which demonstrate that new processes meet acceptance criteria, including capability studies and Gage R&R studies.\nActs as main Quality Engineering contact for assigned customers and projects.\nMay supervise quality technicians and/or inspectors as needed at the manufacturing facility. \nServes as a quality representative to assigned manufacturing areas and/or customers. Responsible for ensuring compliance with Avalign procedures, customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485.\nSupports operations and engineering teams to ensure the Material Review Board process is followed.\nProvides ongoing quality engineering support to operations, including risk management, developing appropriate inspection requirements; and complaint/NC/CAPA investigations.\nSubmit documentation to customers for new product launches and legacy product documentation requests.\n\nCompetencies/Essential Functions: To perform the job successfully, an individual should demonstrate the following:\nLeads assigned team in the development of quality related processes & initiatives. \nMonitor complaint trends and data in order to escalate emerging issues appropriately.\nIdentify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements\n\nWhat You’ll Need:\nCandidates should have a BS in an engineering science plus at least 5 years of manufacturing experience, or an equivalent combination of education and experience.\nNew production introduction/process development experience in a manufacturing environment highly preferred.\nAn understanding of quality standards (ISO 13485) & regulatory requirements (21CFR820).\nAbility to read and interpret blueprints as well as have a Knowledge of GD&T, and Inspection methods.\nAbility to utilize statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.","description_format":"text","description_chars":3642,"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":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-01T21:37:26Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.855,"p_room":1,"age_days":6,"expected_fill_days":39,"reasons":["conf:0","win:early"],"computed_at":"2026-10-06T05:45:30Z"},"pay":null,"html_url":"https://alion.io/job/avalign-technologies-sr-quality-engineer","json_url":"https://alion.io/job/avalign-technologies-sr-quality-engineer.json","meta":{"generated_at":"2026-10-07T00:35:59Z","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":1044,"day_limit":5000,"remaining_today":3956,"minute_limit":60,"resets_at":"2026-10-08T00:00:00Z"}},"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":3787056},"rest":"https://alion.io/mcp/rest/get_company?id=3787056"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Favalign-technologies-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%2Favalign-technologies-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%2Favalign-technologies-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/avalign-technologies-sr-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Favalign-technologies-sr-quality-engineer"}]}