Junior Quality Engineer, Medical Device QA

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

Job summary

ICU Medical is seeking a Manufacturing Quality Engineer I to support day-to-day QA activities in a regulated medical device environment. You will assist with NCMR coordination, containment, CAPA follow-up, and data-gathering under the guidance of experienced QE staff.

This entry-level role emphasizes 5S, Kaizen, PDCA/8D style problem solving, audit readiness, and collaboration with production and engineering to ensure quality and compliance.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality, Technology, or related discipline.
• 0-2 years of quality, manufacturing, engineering, inspection, or regulated-industry experience preferred.
• Medical device, ISO 13485, FDA QMSR/cGMP, Oracle/ERP, SharePoint, or Power Automate exposure is helpful.

Responsibilities

• Review new NCMRs for completeness of item, lot/serial, quantity, defect description, source, containment status, attachments, photos, and impacted locations.
• Support containment verification, product segregation, evidence collection, DHR/traveler review, inspection/test data review, and related NCMR history gathering.
• Draft routine NCMR investigation summaries, factual complaint support inputs, and recommended next steps for QE II/QE III review.
• Maintain timely updates in SharePoint, Power Automate, Oracle/ERP, or site trackers and elevate aging records or missing information.
• Support CAPA administration by collecting objective evidence, updating task status, preparing implementation records, and following up on assigned actions.
• Recognize and elevate potential CAPA signals, recurrence, complaint severity, field-risk concerns, systemic process-control concerns, or unclear disposition rationale.
• Provide daily manufacturing-floor support for quality questions, line holds, sort/rework verification, inspection criteria clarification, and procedural adherence as assigned.
• Participate in defect-reduction, 5S, visual management, Kaizen, PDCA/A3, and quality-health improvement activities.
• Follow GDP, data integrity, document-control, training, and procedural requirements to maintain audit-ready records.

Skills

GDP knowledge

NCMR workflow

DHR/traveler records

Inspection data

CAPA task support

Regulated manufacturing

5-Why

Fishbone

Pareto

5S

PDCA/A3

Kaizen participation

Basic risk concepts

Education

Bachelor’s degree in Engineering/Science

Tools

Excel

SharePoint

Oracle/ERP

Power Automate

Job description

ICU Medical is seeking a Manufacturing Quality Engineer I to support day-to-day QA activities in a regulated medical device environment. You will assist with NCMR coordination, containment, CAPA follow-up, and data-gathering under the guidance of experienced QE staff.

This entry-level role emphasizes 5S, Kaizen, PDCA/8D style problem solving, audit readiness, and collaboration with production and engineering to ensure quality and compliance.