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ICU Medical

Quality Inspector I

salt lake city, UT

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Job description

Job DescriptionPosition SummaryAble to perform entry level inspection, repetitive tasks associated with visual inspections and basic functional testing knowledge. 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. Ability to perform inspection tasks use microscopes, calipers, and micrometers. Able to complete 10-15 different inspection.Essential Duties & ResponsibilitiesPerform accurate mechanical, physical and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirementsPerform PCI activities for NA Notifications at the US Regional Service Center as needed.Follows all procedural requirements in the area of responsibility in order to maintain compliance to applicable Quality System Regulations (i.e cGMP compliance).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.Initiate Non-Conformance reports as requiredSupports NC and CAPA activities as neededWork on special projects as they may ariseKnowledge, Skills & QualificationsMinimum HS graduate or GED equivalent. AA or Technical Degree preferred.Must have basic computer skills to regularly access and document information in a computer.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.Demonstrated knowledge with medical device regulations and FDA regulatory standards preferred.Education and ExperienceHigh School Diploma is requiredMinimum QualificationsMust be at least 18 years of ageTravel RequirementsTypically requires travel less than 5% of the timePhysical Requirements and Work EnvironmentMust be able to perform essential job functions in an office environment.Long periods of sitting to enter/ analyze data is expectedMust have adequate manual dexterity to operate standard office equipmentMust be able to occasionally lift objects up to 25 lbs.About UsICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.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.We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.Significant US IV solutions manufacturing and supply capabilities.ICU Medical EEO Statement: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.If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at We are committed to providing equal access and opportunities for all candidates.ICU Medical CCPA Notice to Job ApplicantsJob InfoJob Identification 860Job Category ManufacturingDegree Level High School GraduateJob Schedule Full timeLocations Salt Lake City Plant (On-site)

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salt lake city, UT, 84101, US

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