<p>FLSA Status - Non-Exempt</p> <p>Position Summary</p> <p>The Sr. QA Inspector performs testing and inspection of sub-assemblies, final product, commodities, GMP, BOP, safety compliance audits. The Sr. QA Inspector enforces GMP compliance as outlined in internal BOPs. The individual is primarily responsible for testing, inspection and release of product and product components and commodities. The individual records and reports results to provide information necessary to assure that product has been manufactured in accordance with established quality standards.</p> <p>Essential Duties & Responsibilities</p> <ul> <li>Initiate change requests, BOPs, EPWOs, deviations, NCMRs </li><li>Close-out audit work orders and commodity release </li><li>Complete product and part inspection </li><li>Complete sample pulling </li><li>Complete labeling inspection and control </li><li>Provide line clearance approval </li><li>Monitor GMP practice </li><li>Quarantine and release quarantined materials </li><li>Train new employees and team on GMP and BOPs </li><li>Must perform defect tracking, monthly reporting and data entry </li><li>Complete test requests </li><li>Ensures departmental compliance to all Federal, State, Local and Company regulatory requirements. These elements include FDA, EPA, OSHA, ISO, EEOC and Company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training and safety (equipment, associate and material). </li><li>Perform these and other duties as necessary or required, the inclusion of which will not alter the basic scope of the position </li><li>Work on special projects as they arise </li><li>Actively demonstrating support through interactions with solid communication skills, attitude, dedication, commitment, respect, pride and trust. </li></ul> <p>Knowledge, Skills & Qualifications</p> <ul> <li>Excellent Mathematical knowledge </li></ul> <p>Education and Experience</p> <ul> <li>Must be 18 years of age </li><li>High School Diploma or GED required </li><li>One year previous experience as an MQA or QA Inspector preferred </li><li>Experience with medical devices/pharmaceutical GMPs preferred </li></ul> <p>Physical Requirements and Work Environment</p> <ul> <li>While performing the duties of this job, the employee is regularly required to talk or hear. </li><li>This job operates in a clean room environment. </li><li>While performing the duties of this job, the employee may be required to sit or stand for the duration of the shift </li><li>Must be able to repetitively move and lift objects of up to 20 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 fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and 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 identity, gender expression, gender reassignment, 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>OFCCP Equal Opportunity Posters</p> <ul> <li>"Know Your Rights" Poster </li><li>Pay Transparency Nondiscrimination Provision </li></ul> <p>ICU Medical CCPA Notice to Job Applicants</p>