Engineer III, Quality-Manufacturing

JOB DESCRIPTION

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. 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. Position Summary 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. 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. Essential Duties & 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. Knowledge, Skills & Qualifications 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. 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; 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. Green Belt certification expected or strongly preferred. ASQ CQE, lead auditor, or equivalent quality certification preferred. 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. About Us 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 View email address on click.appcast.io. We are committed to providing equal access and opportunities for all candidates. ICU Medical EEO Policy Statement Know Your Rights: Workplace Discrimination is Illegal Poster ICU Medical CCPA Notice to Job Applicants #J-18808-Ljbffr ICU Medical