Engineer III, Quality-Manufacturing

ICU Medical•Salt Lake City, UT

3d•Hybrid

About The Position

The Manufacturing Quality Engineer III is an advanced Quality Engineer and technical lead responsible for complex investigations, CAPA quality, manufacturing quality-health improvement, risk-based process control, and cross-functional problem solving. The role leads defect-reduction projects and mentors developing Quality Engineers.

Requirements

Advanced knowledge of complex investigation leadership, CAPA root cause/action/effectiveness, complaint technical conclusions, process-control review, validation/change support, PFMEA/control plan linkage, SPC/capability, and risk management.
Green Belt-level DMAIC skill, Kaizen facilitation, A3/PDCA, advanced root cause analysis, project governance, technical mentoring, presentation skills, and data-driven quality-health management.
Ability to influence Manufacturing, Engineering, Quality Systems, Supplier Quality, Operations, and leadership toward sustainable quality improvements.
Strong audit readiness, technical writing, communication, and cross-functional decision-making capability.
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; advanced degree or equivalent experience helpful.
At least 4-7 years’ relevant experience of quality engineering, manufacturing quality, process engineering, supplier quality, or regulated manufacturing experience.
Demonstrated experience leading complex NCMRs, CAPAs, complaint investigations, process-control improvements, and cross-functional problem solving.

Nice To Haves

Green Belt certification expected or strongly preferred.
ASQ CQE, lead auditor, or equivalent quality certification preferred.

Responsibilities

Lead complex NCMRs involving recurrence, high cost, multi-lot impact, unclear root cause, process-control weakness, validation linkage, supplier/manufacturing interface, or potential customer/field impact.
Define investigation strategy, required evidence, containment rigor, risk rationale, disposition logic, and escalation requirements for complex records.
Review and coach QE I/QE II NCMR, complaint, and CAPA records for technical quality, GDP, and closure readiness.
Support CAPA Owners with complex manufacturing quality issues by reviewing investigations, root causes, corrective actions, supporting evidence, and effectiveness checks.
Lead complex internal and external complaint manufacturing reviews, including linkage to NCMR, CAPA, supplier, process, and field history.
Serve as technical quality lead for assigned manufacturing areas, including process-control health, validation support, PFMEA/control plan linkage, acceptance criteria, inspection strategy, and procedure/training improvements.
Occasionally support process changes for quality risk, verification/validation needs, inspection impacts, supplier impacts, and QMS record requirements.
Lead medium-to-large cross-functional continuous-improvement projects tied to NCMR reduction, complaint reduction, CAPA effectiveness, process capability, scrap/rework reduction, or systemic process-control improvement.
Facilitate Kaizen events by defining scope, pre-work, metrics, team roles, current/future state, root-cause logic, implementation actions, and sustainment plans.
Mentor QE I/QE II personnel on investigations, CAPA thinking, complaint reviews, risk-based disposition, data analysis, CI methods, and technical writing.