Engineer II, Quality

Position Summary:

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.

Essential Duties & 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.

Knowledge, Skills & Qualifications:

• 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.

Education and Experience:

• 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.

Physical Requirements and Work Environment:

• This role requires both manufacturing and office environment.

• While working in the manufacturing environment, high-noise areas, radiological hazards, lasers, and/or biological hazards may be encountered.

• Lift up to 40 lbs unassisted.

• Typically requires travel less than 5% of the time.

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

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