Position Summary Works in a Quality Systems environment to ensure that the servicing of infusion pumps meet the requirements of ISO 13485-2016, 21 CFR Part 820, and other applicable regulations and standards. This position also supports key areas to maintain an effective Quality System such as: quality operations, complaint investigations, CAPA investigation, risk management, internal audit, service data collection, analysis and trending. The incumbent encompasses a qualify professional that can work and develop within a quality management system and with the sufficient skills, experience and competences to work in a regulated environment and very dynamic role. * * Essential Duties & Responsibilities • Support and provide Quality oversight to the Hub Service/Repair Operations and/or Field Service • Engineering organization, and Warehouse team in their daily activities. • Maintain documentation and records resulting from quality management system activities and • according to established procedures. • Perform customer complaints analysis for unreturned serialized devices. • Process Quality holds. • Initiate and complete Quality Investigations to identify root cause and implement effective • solutions (corrective and preventive actions) for product/process quality issues, corporate/external • audit observations and quality system compliance issues as required. • Utilize technical background (including statistical knowledge and root cause analysis tools) to assist • in data collection, analysis and reporting associated to process improvement but also as input to • management for decision making. • Actively participates in preventive/proactive quality and operations improvement projects. • Provide inputs to the Global Service Quality Management Review and monthly Operational • Review meetings. • Support Quality Management on site readiness activities associated with external audits and • regulatory inspections (can be asked to present and defend in the front room complaint analysis and • other Service QMS topics) • Contribute to the oversight on the site regulatory compliance, including follow up to regulatory • commitments. • Oversight and drive improvements to meet established quality objectives and performance • indicators goals associated to tasks under responsibility. • May support validation processes and risk assessments as required. • Provide support to initiate Change Request packages for Quality System procedure changes. • May lead or coordinate remediation plans associated to Quality System compliance issues. • Ensure fulfillment of compliance training requirements per established schedule. • May conduct internal audits per established internal audit schedule and as designated by Quality • Management. • Perform other related duties as assigned or required. • Work on special projects as they arise. Knowledge, Skills & Qualifications • 2 years hands on experience working in a regulated medical device environment • Superior technical writing and problem solving skills required • Superior written and verbal communication skills, capable of synthesizing a problem • statement/situation/observation and providing a concise synopsis to upper management • Ability to work in a fast paced environment and multi-task. • Must be capable of organizing data from multiple sources, extracting key information and writing • technical reports with executive summaries including statistical analysis of data • Combined education plus work experience in a medical device industry will effectively align • incumbent with his/her ability to contribute to the organization • Demonstrated knowledge with medical device regulations and experience with FDA regulatory • standards and ISO 13485 • Working knowledge of basic statistical techniques required • Advanced knowledge and experience in root cause analysis (RCCA) and problem solving techniques • Intermediate working knowledge of Excel (pivot table, filtering, graphing), Word and PowerPoint Education and Experience • Bachelor’s degree from an accredited college or university (STEM discipline) • 2-4 years experience • CQE, CQA is preferred • ISO 13485 Lead Auditor certification a plus Minimum Qualifications · Must be at least 18 years of age Travel Requirements · Typically requires travel less than 5% of the time ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected. Title: Quality Engineer II Location: UT-Salt Lake City Requisition ID: 24300038