Entry-Level Quality Engineer I: Manufacturing QA

ICU Medical, Inc.; Salt Lake City (UT); On-site; USD 55,000 - 75,000; Full time

Job summary

ICU Medical, Inc. in Salt Lake City, UT, is seeking a Manufacturing Quality Engineer I to support day-to-day QA activities in a regulated medical device environment.

The role assists with NCMR coordination, containment documentation, routine investigation support, CAPA task follow-up, and evidence gathering under the direction of more experienced Quality Engineers. Essential duties include reviewing NCMRs, supporting containment, drafting routine investigation summaries, and maintaining records

Qualifications

• Bachelor's degree in Engineering, Science, Quality, Technology, or related discipline; 0-2 years of quality/manufacturing/regulated-industry experience preferred.
• Developing knowledge of GDP, NCMR workflow, containment, DHR/traveler records, inspection/test data, complaint support, CAPA task support.
• Familiarity with Excel, SharePoint, Oracle/ERP, and Power Automate is beneficial.

Responsibilities

• Review new NCMRs for completeness including item, lot/serial, quantity, defect description, source, containment status, attachments, photos, and impacted locations.
• Support containment verification, product segregation, evidence collection, and data review.
• Draft routine NCMR investigation summaries and support inputs for QE review.
• Maintain updates in SharePoint, Oracle/ERP, or site trackers and escalate aging records.
• Assist CAPA administration by collecting evidence, updating task status, and following up on actions.
• Provide daily manufacturing-floor support for quality questions, line holds, and inspection criteria clarification.

Skills

GDP basics

NCMR workflow

DHR/traveler records

Inspection/test data

CAPA task support

Regulated manufacturing

Education

Bachelor's degree in engineering/science/quality

Tools

Excel

SharePoint

Oracle/ERP basics

Power Automate

Job description

ICU Medical, Inc. in Salt Lake City, UT, is seeking a Manufacturing Quality Engineer I to support day-to-day QA activities in a regulated medical device environment.

The role assists with NCMR coordination, containment documentation, routine investigation support, CAPA task follow-up, and evidence gathering under the direction of more experienced Quality Engineers. Essential duties include reviewing NCMRs, supporting containment, drafting routine investigation summaries, and maintaining records