Hiring: Engineer II, Quality Company: ICU Medical Location: Dublin, OH Job Posted Time: 2026-09-12 12:20:41 Employment Type: On-site Target Skills & Keywords : EHR, Lean Manufacturing, Project Management, R About the job Experience: •Must be at least 18 years of age •2-4 years of experience •Previous regulated industry experience preferred Required Skills: •This role is 100% onsite at our Dublin, OH manufacturing facility. •Owns or drives non-conforming reports (NCMRs/NCRs) and CAPAs from initiation to closure. •Performs NCMR Tracking & Trending (Data Analysis) to identify improvements for systemic issues •Uses problem-solving tools (Ex: 5WHYs, Ishikawa etc.) to perform root cause investigations •Ensures maintenance or updating of risk documents such as PFMEAs, DFMEAs etc. •Ensures compliance with Quality System Regulations (Ex: QSR 21CFR820 and ISO-13485) •Support qualification activities such as IQ, OQ, PQ; Test Method Validations (TMV), Gage R&R/MSA •Perform statistical analysis of various types of manufacturing data using tools such as Minitab Qualifications: •The MQ Quality Engineer role receives general direction daily from Quality Engineering Management. The position requires both performance of duties in a manufacturing and office environment. •Work is performed in a clean room environment. This requires the ability to adhere to the cGMP requirements of the area. •There are high noise areas, areas where radiological hazards or lasers may be encountered and/or areas where biological hazards may be encountered. •Must be able to occasionally move and lift objects of up to 40 lbs. unassisted •This job operates in a professional office environment and routinely uses standard office equipment. •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. 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!