{"id":2575226,"url":"https://alion.io/job/ambu-quality-engineer","title":"Quality Engineer","company":{"id":2093467,"name":"Ambu","domain":"ambu.com","url":"https://alion.io/company/ambu-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Career sitemap","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Noblesville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":57000,"max_usd":103000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":3735},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-14T23:57:15Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-15T23:06:38Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"We are seeking a Quality Engineer with experience in medical device design quality and risk management to support product development from concept through commercialization. This role will primarily support R&D and Process Engineering activities to ensure compliance with design controls and risk management requirements.\nThe ideal candidate must have hands-on experience with design controls and risk management, including FMEA and structured problem-solving methodologies, and a solid understanding of ISO 13485, 21 CFR 820, and ISO 14971 requirements to identify and mitigate potential compliance, product and patient safety risks.\nObjective:\nThe objective of this position is to provide the level of resource necessary to maintain, monitor and improve the Quality Management System (QMS) for Ambu USNV, to ensure compliance with regulatory requirements and established local and Corporate practices.\nResponsibilities and Essential Functions (Applicable to all positions listed above):\nIdentify and implement effective quality control systems to support on-going manufacturing and product/process development activities to meet internal and customer requirements. \nAssist in the improvement and streamlining of quality practices across the organization to effectively identify and resolve quality issues.\nApply sound and systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.\nResponsible for product and process risk management activities.\nSupport the review, investigation, resolution and prevention of product and process nonconformances (NCRs) to meet established internal requirements.\nDevelop rework procedures to support NCR activities.\nAct as a handler for Corrective Actions/Preventive Actions (CAPA) system activities to drive proper risk evaluation, investigation, and implementation of actions.\nSupport CAPA verification of effectiveness (VOE) activities.\nTracking, trending, and monitoring Quality key performance indicators (KPIs).\nReport quality KPIs to Quality Review Board (QRB).\nParticipate in CAPA Review Board (CRB) meetings, as necessary.\nReview calibrations out of tolerance assessments (OOTAs) and support with calibration remedial actions reports (RARs).\nResponsible for change control activities related to quality documentation, such as updates to procedures, instructions, forms, risk management documentation, etc.\nQuality functional approver for product and process changes as a subject matter expert (SME) of assigned areas.\nSupport Document Controls activities, as necessary.\nDevelop new and/or improve quality documentation (procedures, instructions, forms, ect.).\nWrite and execute spreadsheet validation documentation, as necessary.\nProvide quality engineering support to process improvements and product/process development projects to ensure implementation of highest quality solutions.\nSupport complaint investigations, as necessary.\nBecome part of the internal auditing team as a certified auditor.\nSupporting backroom activities during external audits, as necessary.\nProvide guidance to less experienced staff.\nPerform other related duties and responsibilities, as assigned.\nResponsibilities and Essential Functions - Engineer II, Quality:\nResponsible for, at a minimum, one critical functional area of the Quality Management System (QMS) (e.g., CAPA, NCR, Deviations, etc.).\nIdentify and implement activities geared to standardize and streamline quality practices across the organization to improve QMS efficiency and maintain its effectiveness.\nLead and provide guidance to the rest of the organization in proper root cause investigation techniques.\nProvide guidance on the use of statistical techniques for selection of sampling strategies and analysis of data.\nFacilitate CRB, QRB, and Management Review meetings.\nResponsible for data trending and preparation for Management Reviews and Corporate Management Reviews.\nWrite and execute Test Method Validation (TMV) documentation related to Quality Assurance inspection methods, as necessary.\nQualifications:\nLevel: Engineer\nBachelor’s degree in Engineering or technical field equivalent experience.\n1 - 2 years of experience working in quality and/or quality engineering roles. Within the medical device manufacturing industry is preferred.\nLevel: Engineer II\nBachelor’s degree in Engineering or technical field equivalent experience.\n2 - 5 years of experience working in quality and/or quality engineering roles. Within the medical device manufacturing industry is preferred.\nWorking technical knowledge and application of quality concepts, practices, and procedures.\nRequired skills:\nExperience with ISO 13485 and/or 21 CFR Part 820.\nAbility to travel nationally and internationally up to approximately 5% of a year’s time.\nGood attention to detail and organizational skills.\nProficient at applying analytical and problem-solving tools and methodologies.\nAbility to work, interact, and communicate effectively with others.\nAbility to work within a team and as an individual contributor in a fast-paced, changing environment.\nEffective verbal and written communication skills.\nGreat technical writing skills.\nProficiency with Microsoft Office (Word, Excel, PowerPoint).\nMust be able to read, write and understand English.\nPreferred skills:\nAuditor or Lead Auditor certification.\nExperience with EU MDR 2017/745.\nExperience with ISO 14971.\nWork Environment:\nThis is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.","description_format":"text","description_chars":5662,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-10-14T23:57:15Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":0,"expected_fill_days":3,"reasons":["conf:2","velocity","win:early","comp:junior"],"computed_at":"2026-10-15T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/ambu-quality-engineer","json_url":"https://alion.io/job/ambu-quality-engineer.json","meta":{"generated_at":"2026-10-16T00:29:03Z","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_verified","counted_by":"address","units_charged":1,"used_today":889,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-17T00:00:00Z"}},"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":2093467},"rest":"https://alion.io/mcp/rest/get_company?id=2093467"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fambu-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%2Fambu-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%2Fambu-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/ambu-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fambu-quality-engineer"}]}