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ICU Medical Quality Inspector I (Rotating 12 Hour Night Shift) in Salt Lake City, Utah

Job Title

Quality Inspector (NIght Shift Rotating 12 Hour Schedule)

Shift 6:00 PM to 6:30 AM

FLSA Status Non-Exempt

Position Summary

Independently performs inspections on parts, materials, and supplies received from vendors, perform in-process production inspections, and ensure products comply with quality standards prior to shipment. Issues acceptance or rejection tags based on outcome of inspections, checking with supervisor on more difficult determinations. Familiar with manufacturing environment, inspecting, testing, sampling, and sorting of products / goods being manufactured.

Essential Duties & Responsibilities

• Audit and monitor quality requirements in accordance with company quality assurances policies and customer specifications.

• Conduct inspections at First Article, in-process, in-coming and completes the final inspections.

• Perform accurate mechanical, physical and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirements.

• Initiate Non-Conformance reports as required.

• Perform product identification and traceability activities; Input and perform trending of key inspection process metrics.

• Follows all procedural requirements in the area of responsibility in order to maintain compliance to applicable Quality System Regulations (i.e. cGMP compliance).

• May perform PCI activities for all NA Notifications at the US Regional Service Center as needed.

• Work on special projects as they arise.

Knowledge, Skills & Qualifications

• 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 Experience

• High School diploma or GED equivalent

• AA or Technical Degree preferred

• Minimum of 6 months of experience required

Minimum Qualifications

• Must be at least 18 years of age

Travel Requirements

• Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

• Repair line area and the Warehouse

• Some lifting is required in order to inspect completed devices during the release process as well as lifting incoming parts awaiting incoming inspection

• Must be able to occasionally move and lift objects of up to 30 lbs.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Title: Quality Inspector I (Rotating 12 Hour Night Shift)

Location: UT-Salt Lake City

Requisition ID: 21300145

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