Manufacturing Quality Engineer II - Process & CAPA

Socket.dev

Salt Lake City (UT)

On-site

USD 70,000 - 90,000

Full time

4 days ago

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Job summary

ICU Medical is seeking a Manufacturing Quality Engineer II to independently support routine QA for a designated product line, leading NCMR investigations and CAPA assessments. You will conduct root cause analyses and contribute to risk-based decisions during manufacturing reviews.

You will also prepare quality-health summaries, drive defect-prevention actions, and mentor QE staff on record quality and CI tracking.

Qualifications

Bachelor’s degree in Engineering, Science, Quality, Technology, or related discipline.
Typically 2–5 years of quality or manufacturing engineering experience.
Experience with NCMRs, CAPA, and root-cause analysis.
ASQ CQE certification or equivalent quality training is a plus.
Yellow Belt expected or strongly preferred; Green Belt training recommended.

Responsibilities

Own routine NCMR investigations from initial evaluation through closure.
Support CAPA initiation assessments with evidence-based recommendations.
Lead or support root cause analysis using 5-Why, fishbone, Pareto, stratification, trend charts.
Provide independent production quality support for line investigations and risk assessments.
Present monthly area quality-health summaries.
Coach QE I or Quality Specialist on records and CI action tracking.