Job Duties: Supplier Quality Engineering Site Representative for ICU Medical Salt Lake Facility. Manages incoming material quality via resolution of supplier non conformances (NCs) and SCARs. Drives supplier change notices (SCNs), management review metrics, reports, and scorecards. Provides support for elevated issues such as recalls, field alerts, complaints, and product investigations. Supports the maintenance of the approved supplier listing (ASL) due to changes to suppliers. Performs supplier audits and on-time delivery of audit reports to meet regulatory requirements. Reviews and release incoming batch records as needed. Ensures supplier changes impacting ICU Medical products/processes or supply base are approved and compliant to existing QMS requirements. Performs supplier qualification. Regularly interfaces with a large cross functional team comprising of R&D, Process/Manufacturing Engineering, Operations, Purchasing, Planning etc.. Uses problem-solving tools (Ex: 5WHYs, Ishikawa etc.) to perform root cause investigations. Ensures compliance with Quality System Regulations (Ex: QSR 21CFR820 and ISO-13485). Owns or drives non-conforming reports (NCMRs/NCRs) and CAPAs from initiation to closure. Conducts Gemba walks of the manufacturing areas to identify compliance risks and propose mitigations. Interfaces with external suppliers to resolve supplier quality issues. Creates data analysis charts, pareto charts etc., management meeting slides etc. and presents to leadership. Trains or mentors junior engineers with technical writing, quality concepts and on the job training. Performs other related duties as assigned or required. *<5% domestic travel required. *Hybrid work is permitted. When not working from home, must report to Salt Lake City, UT office.

Special Skills Required: Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be "quantified" by "time." Required expertise/knowledge includes: Knowledge of the Medical Device Industry and FDA QSR regulations, including 21CFR820 & ISO13485; Understanding of automation, medical-device assembly, manufacturing processes, and conducting audits on medical device manufacturing; Knowledge of Six-Sigma Methodology (DOE, Process Capability, and Gage Repeatability & Reproducibility); Experience with Non-Conformances, Root Cause Investigation Tools (5Whys, Ishikawa/Fishbone Analysis), and Corrective & Preventative Actions (CAPAs); Experience with supplier change control, supplier qualifications, and supplier corrective actions; Experience with engineering technical writing and reading/interpreting engineering drawings; Knowledge of statistical analysis using Minitab and measurement system analysis (MSA).

Education/Experience Required: Bachelor's degree (or foreign equivalent) in Biomedical Engineering, Material Science Engineering, Mechanical Engineering, Electrical Engineering or closely related engineering field plus Four (4) years of experience in the job offered or a closely related occupation.