Job Description
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.
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.
