Quality Inspector I

ICU Medical • Salt Lake City, UT

4d • Onsite

About The Position

Able 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.

Requirements

• Minimum HS graduate or GED equivalent.
• 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.
• Ability to perform inspection tasks use microscopes, calipers, and micrometers.
• Able to complete 10-15 different inspection.

Nice To Haves

• AA or Technical Degree preferred.
• Demonstrated knowledge with medical device regulations and FDA regulatory standards preferred.

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.
• 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 required.
• Supports NC and CAPA activities as needed.
• Work on special projects as they may arise.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED