Hiring: Engineer I, Quality Company: ICU Medical Location: Salt Lake City, UT Job Posted Time: 2026-09-10 12:20:41 Target Skills & Keywords : EHR, Microsoft Excel, Quality Assurance, Six Sigma About the job Experience: •Must be at least 18 years of age. •0-2 years of quality, manufacturing, engineering, inspection, or regulated-industry experience preferred. •Medical device, ISO 13485, FDA QMSR/cGMP, Oracle/ERP, SharePoint, or Power Automate exposure is helpful. •Six Sigma and Lean awareness recommended. Required Skills: •Review new NCMRs for completeness of item, lot/serial, quantity, defect description, source, containment status, attachments, photos, and impacted locations. •Support containment verification, product segregation, evidence collection, DHR/traveler review, inspection/test data review, and related NCMR history gathering. •Draft routine NCMR investigation summaries, factual complaint support inputs, and recommended next steps for QE II/QE III review. •Maintain timely updates in SharePoint, Power Automate, Oracle/ERP, or site trackers and escalate aging records or missing information. •Support CAPA administration by collecting objective evidence, updating task status, preparing implementation records, and following up on assigned actions. •Recognize and escalate potential CAPA signals, recurrence, complaint severity, field-risk concerns, systemic process-control concerns, or unclear disposition rationale. •Provide daily manufacturing-floor support for quality questions, line holds, sort/rework verification, inspection criteria clarification, and procedural adherence as assigned. •Participate in defect-reduction, 5S, visual management, Kaizen, PDCA/A3, and quality-health improvement activities. 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!