Engineer I, Quality

ICU Medical • Salt Lake City, UT

5d • Hybrid

About The Position

The Manufacturing Quality Engineer I is an entry/developing role that supports day-to-day manufacturing quality assurance activities in a regulated medical device manufacturing environment. The role assists with NCMR coordination, containment documentation, routine investigation support, CAPA task follow-up, complaint evidence gathering, and continuous improvement actions under the direction of more experienced Quality Engineers.

Requirements

• Basic understanding of GDP, NCMR workflow, containment, DHR/traveler records, inspection/test data, complaint support, CAPA task support, and regulated manufacturing expectations.
• Developing skill in 5-Why, fishbone, Pareto, check sheets, basic process mapping, 5S, PDCA/A3, Kaizen participation, and basic risk concepts.
• Ability to communicate clearly, ask for help early, follow through on assignments, and maintain accurate documentation.

Nice To Haves

• Working knowledge of Excel, SharePoint, Oracle/ERP basics, and Power Automate workflow awareness preferred.
• Medical device, ISO 13485, FDA QMSR/cGMP, Oracle/ERP, SharePoint, or Power Automate exposure is helpful.
• Six Sigma and Lean awareness recommended.

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 escalate 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 escalate 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level