ICU Medical Quality Inspector II (day shift - rotating 12 hour) in Salt Lake City, Utah
QA Inspector II
Days - Rotating 12 hour shift
6:00am - 6:30pm
This individual will perform moderately complex, repetitive tasks associated with quality inspections. 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. Perform varied product inspections, generally of finished goods, components, incoming and outgoing materials or new products, by observing, measuring and recording data. Compare inspection results to defined requirements or specifications and documents differences found. Have competencies in various inspection and ability to work in various clean rooms.
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
• Able to understand and take directions. Able to perform basic operations on smart scope.
• 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 required
• AA or Technical Degree preferred
• Minimum of 2 years of experience required
• Must be at least 18 years of age
• 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 II (day shift - rotating 12 hour)
Location: UT-Salt Lake City
Requisition ID: 21300032