Quality Engineer

Position Title: Quality Engineer

Department: Quality

Reports to: Lead Complaints Management and Continuous Improvement

Location: Huntersville, NC

Summary:

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 Responsibilities

• Lead 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 activities
• Lead cross-functional problem-solving teams
• Validate effectiveness of corrective actions and drive permanence and eliminate recurrence.
• Drive all continuous improvement projects
• Data analysis and reporting:
• Customer Complaint Trends
• COPQ
• NCR Metrics
• Supplier Performance
• Audit Findings
• CAPA Status
• Customer Satisfaction
• Lean Six Sigma Projects/Continuous Improvement
• Maintain ISO9001:2015 compliance thru:
• Supporting internal and external audits
• Updating procedures, work instructions and process documentation
• Supporting document control initiatives
• Driving KPIs and closure of CAPA activities
• Drive improvements in:
• First Pass Yield (FPY)
• Right First Time (RFT)
• Process Capability
• Manufacturing Efficiency
• Customer Satisfaction
• PPM Performance
• Utilization of Lean Manufacturing and Six Sigma methodologies

Qualifications

• Technical 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 Analysis
• Software 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 standards
• Competencies: Analytical and problem solving, strong communication and presentation skills, strong organizational and project management skills, data driven decision-making, continuous improvement mindset
• Experience: 3-5 years in quality and manufacturing environment

Educational/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.