Quality Engineer

Position Title: Quality EngineerDepartment: QualityReports to: Lead Complaints Management and Continuous ImprovementLocation: Huntersville, NCSummary:The Quality Engineer is responsible for leading customer complaint investigations, reactive quality activities, continuous improvement initiatives, and supporting the organization’s ISO 9001:2015 Management System (QMS). This role serves as the primary quality representative for customer issues, driving root cause analysis, corrective and preventive actions (CAPA), data analytics and process improvements that improve customer satisfaction while reducing the Cost Poor Quality (COPQ).Key ResponsibilitiesLead the complete customer compliant process from receipt through closure.Review returned products (RMAs) and customer complaints to determine appropriate investigation strategy.Coordinate technical investigations with Manufacturing, Engineering, Product Management, and suppliers.Perform product failure analysis and determine root cause.Ensure timely completion of customer complaint investigations.Prepare technical investigation reports for customers.Communicate investigation results and corrective actions to internal and external stakeholders.Monitor complaint aging and ensure KPI targets are achieved.Identify complaint trends and recommend systemic improvements.Conduct containment activitiesLead cross-functional problem-solving teamsValidate effectiveness of corrective actions and drive permanence and eliminate recurrence.Drive all continuous improvement projectsData analysis and reporting:Customer Complaint TrendsCOPQNCR MetricsSupplier PerformanceAudit FindingsCAPA StatusCustomer SatisfactionLean Six Sigma Projects/Continuous ImprovementMaintain ISO9001:2015 compliance thru:Supporting internal and external auditsUpdating procedures, work instructions and process documentationSupporting document control initiativesDriving KPIs and closure of CAPA activitiesDrive improvements in:First Pass Yield (FPY)Right First Time (RFT)Process CapabilityManufacturing EfficiencyCustomer SatisfactionPPM PerformanceUtilization of Lean Manufacturing and Six Sigma methodologiesQualificationsTechnical Expertise: Proven experience in GD&T (Geometric Dimensioning and Tolerancing), per ASME, Lean Manufacturing, Six Sigma, SPC, MSA, FMEA, Control Plans, PPAP, APQP, 8D, 5Why, Pareto and Statistical AnalysisSoftware Proficiency: Advanced skills in Excel (data modeling/pivot tables), Power BI (dashboard creation), and PowerPoint. Experience using SAP for quality management and Delta Master for business intelligence/reporting is highly preferred, Minitab (preferred).Manufacturing: Strong understanding Food & Bev, Biopharma, Lab and Med manufacturing industry quality standardsCompetencies: Analytical and problem solving, strong communication and presentation skills, strong organizational and project management skills, data driven decision-making, continuous improvement mindsetExperience: 3-5 years in quality and manufacturing environmentEducational/Industry Certification Requirement:A bachelor’s degree in Engineering, Manufacturing Engineering, or a related technical field is a plus.Advanced certification in GD&T (Geometric Dimensioning and Tolerancing)—ASME Y14.5 Professional Certification is highly preferred.ASQ (American Society for Quality) Certifications such as Certified Quality Engineer (CQE) or Certified Calibration Technician (CCT), or ability to acquire within one year.Six Sigma Green or Black Belt to support the Continuous Improvement focus of the role or ability to acquire within one year.