{"id":2683941,"url":"https://alion.io/job/icu-medical-engineer-ii-quality","title":"Engineer II, Quality","company":{"id":11675,"name":"ICU Medical","domain":"icumed.com","url":"https://alion.io/company/icu-medical","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":75,"open_postings":33,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":31,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Salt Lake City, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":61000,"max_usd":111000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4330},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 13485","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-10-08T22:29:26Z","employer_posted_date":"2026-10-08","last_verified_at":"2026-11-05T06:23:17Z","board_verified":true,"closed_at":null,"days_open":27,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":27},"description":"Position Summary\nWorks in a Quality Systems environment to ensure that the servicing of infusion pumps and other serialized medical devices meets the requirements of ISO 13485:2016, 21 CFR Part 820, and other applicable regulations and standards.\nThis position also supports key areas to maintain an effective Quality System, such as: quality operations, complaint investigations, CAPA investigation, risk management, internal audit, and service data collection, analysis, and trending. The incumbent must be a quality\nprofessional that can work and develop within a quality management system and has sufficient skills, experience and competencies to perform in a very dynamic role within a regulated environment.\nEssential Duties & Responsibilities\nSupport and provide Quality oversight to the Hub Service/Repair Operations and/or Field Service Engineering organizations and Warehouse team in their daily activities.\nMaintain documentation and records resulting from quality management system activities according to established procedures.\nPerform customer complaint analyses for unreturned serialized devices.\nProcess Quality holds.\nInitiate and complete Quality Investigations to identify root cause and implement effective solutions (corrective and preventive actions) for product/process quality issues, corporate/external audit observations, and quality system compliance issues as required.\nUtilize technical background (including statistical knowledge and root cause analysis tools) to assist in data collection, analysis, and reporting. This activity may relate to process improvement efforts as well as serve as an input to management for decision making.\nActively participates in preventive/proactive quality and operations improvement projects.\nProvide inputs to the Global Service Quality Management Review and monthly Operational Review meetings.\nSupport Quality Management on site readiness activities associated with external audits and regulatory inspections (can be asked to present and defend in the front room regarding complaint analysis and other Service QMS topics).\nContribute to oversight of site regulatory compliance, including follow-up to regulatory commitments.\nOversee and drive improvements to meet established quality objectives and performance indicator goals associated with tasks under responsibility.\nMay support validation processes and risk assessments as required.\nProvide support to initiate and process Change Request packages for Quality System procedure changes.\nMay lead or coordinate remediation plans associated with Quality System compliance issues.\nEnsure fulfillment of compliance training requirements per established schedule.\nMay conduct internal audits per established internal audit schedule and as designated by Quality Management.\nPerform other related duties as assigned or required.\nWork on special projects as they arise.\nKnowledge, Skills & Qualifications\n2 years hands-on experience working in a regulated industry; medical device experience preferred\nSuperior technical writing and problem solving skills\nSuperior written and verbal communication skills, capable of synthesizing a problem statement, situation, or observation and providing a concise synopsis to upper management\nAbility to work and multi-task in a fast-paced environment\nMust be capable of organizing data from multiple sources, extracting key information, and writing technical reports with executive summaries including statistical analysis of data\nCombined education plus work experience in a medical device industry will effectively align incumbent with his/her ability to contribute to the organization\nDemonstrated knowledge of medical device regulations and experience with FDA regulatory standards and ISO 13485 strongly preferred\nWorking knowledge of basic statistical techniques\nAdvanced knowledge and experience in root cause analysis (RCCA) and problem-solving techniques\nIntermediate working knowledge of Excel (pivot table, filtering, graphing), Word, and PowerPoint\nEducation and Experience\nMust be at least 18 years of age\nBachelor’s degree from an accredited college or university (STEM discipline)\n2-4 years experience\nASQ CQE / CQA certification is preferred\nISO 13485 Lead Auditor certification a plus\nPhysical Requirements and Work Environment\nThis is largely a sedentary role.\nThis job operates in a professional office environment and routinely uses standard office equipment.\nTypically requires travel less than 5% of the 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