Engineer II, Quality

ICU Medical•Salt Lake City, UT

6d•Hybrid

About The Position

The Manufacturing Quality Engineer II is an independent Quality Engineer responsible for routine manufacturing quality assurance support for an assigned product line, process family, workcell, or manufacturing area. The role owns routine NCMRs, complaint manufacturing reviews, CAPA support, quality-health metrics, and proactive defect-prevention activities.

Requirements

Independent knowledge of NCMR ownership, routine investigation leadership, complaint manufacturing review, CAPA support, technical writing, containment, risk-based disposition, and QMS record quality.
Working knowledge of manufacturing-floor support, basic validation/process-control support, PFMEA/control plan linkage, and audit-ready record expectations.
Competency in Pareto analysis, stratification, trend charts, basic SPC/capability, 5-Why, fishbone, A3/PDCA, Kaizen co-leadership, and DMAIC basics.
Strong communication, cross-functional coordination, stakeholder follow-up, and ability to balance documentation execution with proactive defect prevention.
Must be at least 18 years of age.
Bachelor’s degree from an accredited college or university in Engineering, Science, Quality, Technology, or a related discipline; or equivalent combination of education and relevant experience.
Typically 2-5 years of quality engineering, manufacturing engineering, supplier quality, process engineering, or regulated manufacturing experience.
Experience with NCMRs, CAPA support, complaint investigation, process control, root cause analysis, and manufacturing-floor support preferred.
Yellow Belt expected or strongly preferred; Green Belt training/candidate status recommended. ASQ CQE or equivalent quality training is a plus.

Responsibilities

Own routine NCMR investigations from initial evaluation through closure, including containment, affected-product impact assessment, recurrence review, technical rationale, disposition recommendation, and closure logic.
Ensure NCMR records include clear problem statements, objective evidence, investigation summary, product impact assessment, disposition rationale, execution evidence, and timely record updates.
Support CAPA initiation assessments and provide evidence-based recommendations when recurrence, severity, trends, or systemic weaknesses warrant escalation.
Lead or support routine root cause analysis using 5-Why, fishbone, Pareto, stratification, trend charts, and related structured problem-solving tools.
Own manufacturing review portions of internal and external complaints, including production history, NCMR/CAPA history, inspection/test data, potential escapes, and product risk.
Provide independent production quality support for line investigations, rework/sort controls, inspection method clarification, process change review, and manufacturing quality risk assessment.
Support process validation, equipment/fixture qualification, manufacturing transfers, acceptance criteria updates, control plans, and PFMEA maintenance as applicable.
Present monthly area quality-health summaries covering top defects, aging NCMRs, complaint linkages, CAPA signals, and improvement actions.
Lead small-to-medium defect-reduction, documentation, workflow, inspection, process-control, or Kaizen improvement projects and maintain action logs, charters, sustainment plans, and effectiveness checks.
Coach QE I or Quality Specialist personnel on record completeness, CI action tracking, and task follow-up.