<p>Responsibilities</p> <p>Responsible for developing process and procedures to ensure the requirements of ISO 13485-2016, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards are met. Responsible for ensuring smooth integration of service quality processes with Oakdale, MN site by review and updating of SOPs, WIs to replicate service processes at SLC plant. Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality. Review, approve and participate in qualification of acquired software and software tools for servicing purposes. Utilize a wide variety of data sources including product review, global complaints, service quality data to make quality decisions. Monitor product data to identify statistically significant trends and risks. Lead NCRs and CAPA activities as assigned and ensure timely workflow to completion. Support regulatory submissions and responses to regulatory inquires. Work special projects as assigned. <em>Hybrid work is permitted. When not working from home, must report to Salt Lake City, UT office. </em>5% - 10% domestic and/or international travel required per year.</p> <p>EDUCATION AND EXPERIENCE REQUIREMENTS:</p> <p>Bachelor's degree (or foreign equivalent) in Mechanical Engineering, Biomedical Engineering, Software Engineering, or any closely related field plus Seven (7) years of experience in the job offered or closely related occupation in the medical device industry.</p> <p>SPECIAL REQUIREMENTS:</p> <p>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: Experience with ASQ, CQE, or CSQE; Knowledge of quality compliance and experience conducting audits and investigations; Knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, DFMEA, PFMEA, CAPA, SCAR, Complaints, Document Control, etc.); Knowledge of medical device standards, including: ISO 13485 and ISO 14971; Experience with and knowledge of FDA, MDR, and other key medical device regulations; Experience with process development, Validation (IQ, OQ & PQ) and process implementation; Experience taking a systems approach and understanding the interaction between components (i.e. hardware, software, consumables.); PFMEA, RMF, DHR, TMV; Experience working closely with engineering teams and members of a cross functional teams developing SOPs, WIs, Inspection Plans.</p> <p>ICU Medical, Inc. is an equal opportunity employer.</p> <p>To apply for ICU Medical's Senior Engineer, Service Quality position please send resume to: humanresouces@icumed.com</p> <p>Must reference JOB CODE: UT0212ST</p>