Hiring: Engineer II, Quality Company: ICU Medical Location: Salt Lake City, UT Job Posted Time: 2026-09-17 05:20:41 Target Skills & Keywords : EHR, Quality Assurance, Root Cause Analysis About the job Experience: •Must be at least 18 years of age. •Typically 2-5 years of quality engineering, manufacturing engineering, supplier quality, process engineering, or regulated manufacturing experience. •Yellow Belt expected or strongly preferred; Green Belt training/candidate status recommended. ASQ CQE or equivalent quality training is a plus. Required Skills: •Own routine NCMR investigations from initial evaluation through closure, including containment, affected-product impact assessment, recurrence review, technical rationale, disposition recommendation, and closure logic. •Ensure NCMR records include clear problem statements, objective evidence, investigation summary, product impact assessment, disposition rationale, execution evidence, and timely record updates. •Support CAPA initiation assessments and provide evidence-based recommendations when recurrence, severity, trends, or systemic weaknesses warrant escalation. •Lead or support routine root cause analysis using 5-Why, fishbone, Pareto, stratification, trend charts, and related structured problem-solving tools. •Own manufacturing review portions of internal and external complaints, including production history, NCMR/CAPA history, inspection/test data, potential escapes, and product risk. •Provide independent production quality support for line investigations, rework/sort controls, inspection method clarification, process change review, and manufacturing quality risk assessment. •Support process validation, equipment/fixture qualification, manufacturing transfers, acceptance criteria updates, control plans, and PFMEA maintenance as applicable. •Present monthly area quality-health summaries covering top defects, aging NCMRs, complaint linkages, CAPA signals, and improvement actions. Qualifications: •This role requires both manufacturing and office environment. •While working in the manufacturing environment, high-noise areas, radiological hazards, lasers, and/or biological hazards may be encountered. •Lift up to 40 lbs unassisted. •Typically requires travel less than 5% of the time. •ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges. •With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. •We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You •Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization. •The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs. •IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!