<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>Follow all procedural requirements in the area of responsibility in order to maintain compliance to applicable Quality System Regulations (i.e.: cGMP compliance). </li><li>Support the paper document archival process including preparation as well as the scanning of Documents for electronic archival. • 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 and Skills</p> <ul> <li>Basic computer skills in order to regularly access and document information. </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>Ability to perform inspection tasks using microscopes, calipers and micrometers. Ability to complete 10-15 inspections. </li><li>Demonstrated knowledge of medical device regulations and FDA regulatory standards preferred. </li></ul> <p>Minimum Qualifications, Education and Experience</p> <ul> <li>High School graduate or GED equivalent. AA or Technical Degree preferred. </li><li>Must be 18 years of age. </li></ul> <p>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><li>Typically requires travel less than 5% of the time. </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>