Sr. Quality Program Manager, Customer Defect Tracking & Resolution
Core
Lead global intake, triage, tracking, escalation, and communication of customer-reported defects and quality issues to ensure compliance and resolution.
Role type
Senior Quality Program Manager (Customer Defect Tracking)
Builds
Robust, compliant, and scalable defect management processes aligned with QMS and regulatory requirements.
Domain
Life Sciences / Medical Devices / Pharmaceutical Manufacturing
Deliverable
client delivery
Required skills
Quality Management Systems (QMS), CAPA, root cause analysis (RCA), risk management (FMEA), regulatory compliance (FDA, ISO), cross-functional leadership, data analytics, process improvement
Preferred skills
Life sciences/medical devices/pharma manufacturing experience, complaint handling/regulatory reporting, case management systems (Salesforce, ServiceNow, TrackWise, Jira), Lean Six Sigma (Green/Black Belt)
Technologies
Salesforce, ServiceNow, TrackWise, Jira
Responsibilities
Ensure compliance with QMS and global regulatory requirements; lead daily intake and documentation of customer defects; triage and prioritize issues based on risk and impact; assign case ownership and drive cross-functional resolution; serve as central point for defect communications; develop and monitor KPIs for defect metrics.
Seniority
Senior, hands-on IC with leadership capabilities
