<p>This individual will perform moderately complex, repetitive tasks associated with quality inspections. Responsible for ensuring company products are in compliance with internal and external specifications by performing a variety of routine and non-routine inspections and evaluations. Perform varied product inspections, generally of finished goods, components, incoming and outgoing materials or new products, by observing, measuring and recording data. Compare inspection results to defined requirements or specifications and documents differences found. Have competencies in various inspection and ability to work in various clean rooms.</p> <p>Essential Duties & Responsibilities</p> <ul> <li>Perform accurate mechanical, physical and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirements </li><li>Perform PCI activities for NA Notifications at the US Regional Service Center as needed. </li><li>Follows all procedural requirements in the area of responsibility in order to maintain compliance to applicable Quality System Regulations (i.e cGMP compliance). </li><li>Supports the paper document archival process including preparation of pallets for shipment to R4 as well as the scanning of Documents for electronic archival in Agile. </li><li>Initiate Non-Conformance reports as required </li><li>Supports NC and CAPA activities as needed </li><li>Work on special projects as they may arise </li></ul> <p>Knowledge, Skills & Qualifications</p> <ul> <li>Minimum HS graduate or GED equivalent. AA or Technical Degree preferred. </li><li>Must have basic computer skills to regularly access and document information in a computer. </li><li>Must have basic written and oral communication skills adequate to communicate with other team members, understand verbal instructions, and read and comprehend written work instructions including words and engineering drawings. </li><li>Demonstrated knowledge with medical device regulations and FDA regulatory standards preferred. </li></ul> <p>Education and Experience</p> <ul> <li>High School Diploma is required </li><li>Minimum of 2+ years of experience required </li></ul> <p>Minimum Qualifications</p> <ul> <li>Must be at least 18 years of age </li></ul> <p>Travel Requirements</p> <ul> <li>Typically requires travel less than 5% of the time </li></ul> <p>Physical Requirements and Work Environment</p> <ul> <li>Must be able to perform essential job functions in an office environment. </li><li>Long periods of sitting to enter/ analyze data is expected </li><li>Must have adequate manual dexterity to operate standard office equipment </li><li>Must be able to occasionally lift objects up to 25 lbs. </li></ul> <p>ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.</p> <p>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.</p> <p>We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:</p> <ul> <li>Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization. </li><li>The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs. </li><li>IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company. </li><li>Significant US IV solutions manufacturing and supply capabilities. </li></ul> <p>ICU Medical EEO Statement:</p> <p>ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.</p> <p>If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.</p> <p>ICU Medical EEO Policy Statement</p> <p>Know Your Rights: Workplace Discrimination is Illegal Poster</p> <p>ICU Medical CCPA Notice to Job Applicants</p>