{"id":1617446,"url":"https://alion.io/job/histosonics-sr-product-assurance-engineer","title":"Sr. Supplier Quality Engineer","company":{"id":1945754,"name":"HistoSonics","domain":"histosonics.com","url":"https://alion.io/company/histosonics","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","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":["Plymouth, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":110000,"max":140000,"currency":"USD","period":"year","gross":null,"usd_annual":140000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-09-30T22:36:00Z","employer_posted_date":"2026-10-06","last_verified_at":"2026-10-29T22:48:50Z","board_verified":true,"closed_at":null,"days_open":29,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":29},"description":"HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.\nWe offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.\nLocation: Plymouth, MN\nPosition Summary (Why this role matters):\nThe Sr. Supplier Quality Engineer will lead the product assurance activities for commercial production support including inspection, product release, nonconforming material handling, and product complaint analysis. This role will work with Design Assurance on risk management updates and the transfer of design documentation into production and will collaborate closely with suppliers, Manufacturing, and Supply Chain to ensure that product meets requirements.\nKey Responsibilities (What you’ll do):\nLeads product inspection strategy and planning including working with suppliers on purchased product requirements and development of measurement methodologies\nSupports supplier evaluation, auditing, and performance monitoring\nSupports development of in-process and final product testing\nSupports design assurance engineering as needed with risk management activities and review of design documentation including product design requirements and design verification test protocols\nLeads process FMEA (PFMEA) development and ongoing updates\nCollaborates with design assurance and manufacturing engineering to ensure that procedures, practices, and documentation comply with applicable standards and regulations\nSupports the transfer of specifications and processes to production during the design transfer phase\nSupports equipment control and process validations\nReviews Device History Records (DHR) and completes product release\nLeads nonconforming material review and documentation\nUses knowledge of statistics to support inspection, testing, and process validation activities\nPerforms product complaint analysis including associated risk management file reviews and updates\nActs as Subject Matter Expert (SME) during audits and inspections for product inspection, PFMEA, nonconforming material, and product complaint analysis\nDevelops, modifies, and maintains quality system procedures, work instructions, and forms\nSupport internal and external audit activities as needed\nLead CAPA investigations, action planning, and follow-up for assigned CAPAs\nMaintains a safe and clean work environment\nOther duties as assigned \nQualifications and Skills:\nBachelor’s degree in engineering or related technical field\n5+ years of progressive quality engineering experience in Supplier Quality, Quality Operations, or Manufacturing Quality, ideally within the medical device industry or another highly regulated manufacturing environment\nEffective communicator who can work independently and collaboratively across all levels of the organization in a fast-paced, evolving environment\nMultitasks, prioritizes, and meets deadlines in timely manner\nStrong organizational and follow-up skills, as well as attention to detail\nExperience with risk management, nonconforming material, and complaint handling systems\nExperience with practical application of statistics for product inspection and testing\nExperience with FDA 21 CFR Part 820, ISO 13485 and ISO 14971\nApproximately 10% of travel required \nBenefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.\nWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.","description_format":"text","description_chars":4452,"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":["Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Robotics"],"lifecycle":[{"event":"open","at":"2026-10-01T20:37:18Z"},{"event":"close","at":"2026-10-06T14:31:14Z"},{"event":"reopen","at":"2026-10-07T01:35:58Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 4","filings_12m":4,"filings_prev_12m":1,"green_card_filings_12m":0,"median_offered_wage_usd":127500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":76,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.846,"p_room":0.9,"age_days":28,"expected_fill_days":56,"reasons":["conf:1","win:mid"],"computed_at":"2026-10-29T05:49:05Z"},"pay":{"stated_usd_annual":140000,"is_top_pay":true},"html_url":"https://alion.io/job/histosonics-sr-product-assurance-engineer","json_url":"https://alion.io/job/histosonics-sr-product-assurance-engineer.json","meta":{"generated_at":"2026-10-29T23:55:16Z","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":35262,"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":1945754},"rest":"https://alion.io/mcp/rest/get_company?id=1945754"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhistosonics-sr-product-assurance-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%2Fhistosonics-sr-product-assurance-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%2Fhistosonics-sr-product-assurance-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/histosonics-sr-product-assurance-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhistosonics-sr-product-assurance-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1617446}},{"tool":"search_jobs","arguments":{"company":"histosonics.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1617446},"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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