Manufacturing Quality Engineer II - Defect Prevention

ICU Medical; Salt Lake City (UT); On-site; USD 70,000 - 90,000; Full time

Job summary

ICU Medical seeks a Manufacturing Quality Engineer II to own routine NCMR investigations, CAPA support, and manufacturing quality reviews. This role combines QA leadership with hands-on problem solving on the factory floor and in office settings.

You will lead or support root cause analyses, maintain PFMEA linkage, and drive defect-prevention projects while ensuring compliance with QMS records and documentation standards. Travel is minimal and collaboration across departments is common.

Qualifications

• Independent knowledge of NCMR ownership, investigation leadership, and CAPA support.
• Experience with complaint investigation, process control, and record quality.
• Knowledge of PFMEA/control plan linkage and audit-ready records.

Responsibilities

• Own routine NCMR investigations from start to closure with clear statements and evidence.
• Lead CAPA initiation assessments and provide recommendations for escalation when needed.
• Lead or support root cause analysis using 5-Why, fishbone, and related tools.
• Own manufacturing review portions of complaints, including data review and risk assessment.
• Provide QA support for line investigations, changes, and manufacturing risk.
• Support process validation, equipment qualification, and PFMEA maintenance.
• Present monthly area quality-health summaries on defects and actions.
• Drive defect-reduction projects and maintain sustainment plans and logs.

Skills

NCMR ownership

CAPA support

Technical writing

Containment

Risk-based disposition

QMS record quality

PFMEA linkage

Root cause analysis

5-Why

Kaizen co-leadership

DMAIC basics

Cross-functional coordination

Education

Bachelor’s degree in Engineering/Science/Quality or related discipline

2-5 years of quality/manufacturing experience

Job description

ICU Medical seeks a Manufacturing Quality Engineer II to own routine NCMR investigations, CAPA support, and manufacturing quality reviews. This role combines QA leadership with hands-on problem solving on the factory floor and in office settings.

You will lead or support root cause analyses, maintain PFMEA linkage, and drive defect-prevention projects while ensuring compliance with QMS records and documentation standards. Travel is minimal and collaboration across departments is common.