Sr. Quality Program Manager, Customer Defect Tracking & Resolution

Senior Quality Program Manager leading global customer defect intake, triage, tracking, and resolution at a life-sciences organization. The role ensures compliance with quality management systems and regulatory requirements while coordinating cross-functional teams to drive issue resolution and continuous improvement.

Responsibilities

• Lead daily intake, documentation, and case creation of customer-reported defects across multiple channels
• Evaluate and triage issues to determine escalation pathways, severity levels, and prioritization based on risk
• Assign case ownership and lead cross-functional collaboration for investigation and root cause analysis
• Develop and monitor KPIs including response time, resolution time, and defect trends for continuous improvement
• Serve as central coordination point for customer defect communications and stakeholder engagement

Requirements

• Bachelor's degree in Engineering (Quality, Manufacturing, Mechanical, Industrial, or related)
• 7+ years in quality engineering, manufacturing engineering, or related technical field
• Experience managing customer complaints and defect tracking in regulated environments
• Strong knowledge of Quality Management Systems, CAPA, root cause analysis, and risk management
• Proven ability to lead cross-functional teams and manage multiple priorities
• Life sciences, medical devices, diagnostics, or pharmaceutical manufacturing experience preferred
• Familiarity with complaint handling and regulatory reporting requirements (MDR, vigilance reporting)