Quality Inspector I

About the Role

Able to perform entry-level inspection, repetitive tasks associated with visual inspections, and basic functional testing. Responsible for ensuring company products comply with internal and external specifications by performing routine and non-routine inspections and evaluations. Proficient in using microscopes, calipers, and micrometers to complete 10-15 different inspection tasks.

Responsibilities

• Perform accurate mechanical, physical, and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirements.
• Perform PCI activities for NA Notifications at the US Regional Service Center as needed.
• Follow all procedural requirements to maintain compliance with applicable Quality System Regulations (e.g., cGMP compliance).
• Support the paper document archival process, including preparation of pallets for shipment and scanning documents for electronic archival in Agile.
• Initiate Non-Conformance reports as required.
• Support NC and CAPA activities as needed.
• Work on special projects as they arise.

Requirements

• Minimum High School Diploma or GED equivalent; AA or Technical Degree preferred.
• Basic computer skills to access and document information.
• Basic written and oral communication skills to interact with team members, understand instructions, and read work instructions and engineering drawings.
• Demonstrated knowledge of medical device regulations and FDA regulatory standards is preferred.
• Must be at least 18 years of age.
• Travel typically less than 5% of the time.

Physical Requirements and Work Environment

• Ability to perform essential job functions in an office environment.
• Long periods of sitting to enter/analyze data.
• Adequate manual dexterity to operate standard office equipment.
• Occasional lifting of objects up to 25 lbs.

About Us

ICU Medical consistently delivers clinical innovations to 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. Our focus allows us to provide 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, IV medication safety software with full IV-EHR interoperability, and significant US IV solutions manufacturing and supply capabilities.