Hiring: Quality Engineer II, Sustaining & Validation Company: ICU Medical Location: Salt Lake City, UT Job Posted Time: 2026-09-10 12:20:41 Target Skills & Keywords : Agile, Assembly, EHR, Microsoft Office, Product Lifecycle Management, Project Management, Quality Assurance, R, Regulatory Compliance, Risk Management About the job Experience: •Must be at least 18 years of age •2-4 years’ experience working in a regulated manufacturing or pharmaceutical/healthcare environment required. Prior experience in quality is preferred. •Proficiency in using validation software and other relevant tools (e.g., Minitab, statistical analysis software). •Strong knowledge of medical device validation processes, risk management, and regulatory requirements (FDA 21 CFR Part 820, ISO 14971, ISO 13485). Required Skills: •Demonstrate an understanding and functional impact of changes to critical process in the manufacturing and testing of ICU products. •Develop and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, processes, and software systems. •Conduct risk assessments to identify critical quality attributes (CQAs) and critical process parameters (CPPs) for validation. •Create and review Quality Control Plans and process FMEA’s, Ensure validation documentation is accurate, complete, and in accordance with regulatory and quality system requirements. •Maintain validation master plans, protocols, and reports as part of the company’s quality system documentation. •Improve the Quality Management System through internal audits and supporting regulatory audits. •Lead and support the validation of new and existing manufacturing processes, ensuring compliance with FDA regulations, ISO 13485 standard, and company quality systems. •Develop and execute Test Method Validations for manufacturing processes and laboratory equipment, as needed Qualifications: •This is largely a sedentary role. •This job operates in a professional office environment and routinely uses standard office equipment. •Work is partly performed in a clean room environment •Must be able to occasionally move and lift objects of up to 25 lbs •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. 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!