Sr. Quality Program Manager, Customer Defect Tracking & Resolution

Thermo Fisher Scientific is a leading company in the healthcare industry, dedicated to enabling customers to make the world healthier, cleaner, and safer. They are seeking a Sr. Quality Program Manager to lead the global intake, triage, tracking, escalation, and communication of customer-reported defects and quality issues, ensuring compliance with their Quality Management System and regulatory standards.

Responsibilities:

• Ensure all customer defect tracking and resolution activities comply with Thermo Fisher’s QMS, including alignment with CAPA, complaint handling, and escalation processes
• Maintain compliance with applicable global regulatory requirements (e.g., FDA 21 CFR Part 820/210/211, ISO 13485, ISO 9001, as applicable)
• Support audit readiness and participate in internal and external audits related to customer complaints and defect management
• Lead the daily intake and documentation of customer-reported defects across multiple channels
• Ensure accurate and complete case creation, including assignment of unique identifiers and proper documentation within approved systems
• Establish and maintain standardized severity classification criteria to assess risk and customer impact
• Evaluate and triage incoming issues to determine appropriate escalation pathways and urgency
• Assign severity levels and prioritize cases based on product risk, regulatory impact, and customer criticality
• Drive immediate response and visibility for high-severity or critical escalations
• Assign case ownership to appropriate functions (e.g., Quality, Manufacturing, R&D, Supply Chain, Customer Support)
• Lead cross-functional collaboration to ensure timely investigation, root cause analysis, and resolution
• Track progress, ensure accountability, and proactively remove barriers to resolution
• Serve as the central point of coordination for customer defect communications
• Ensure consistent, accurate, and timely communication across internal stakeholders and customer-facing teams
• Consolidate communications for similar or recurring issues to maintain alignment and clarity
• Provide regular status updates to leadership and stakeholders on open and critical cases
• Develop and monitor key performance indicators (KPIs), including response time, resolution time, backlog, and recurrence trends
• Analyze defect data to identify systemic issues and drive preventive actions
• Partner with Quality and Engineering teams to implement corrective and preventive actions (CAPA)
• Drive process improvements to enhance efficiency, compliance, and customer experience

Requirements:

• Bachelor's degree in Engineering (Quality, Manufacturing, Mechanical, Industrial, or related discipline)
• 7+ years of experience in quality engineering, manufacturing engineering, or a related technical field
• Demonstrated experience managing customer complaints, defect tracking systems, or escalation processes within a regulated environment
• Strong knowledge of Quality Management Systems (QMS), including CAPA, root cause analysis (RCA), and risk management tools (e.g., FMEA)
• Proven ability to lead cross-functional teams and manage multiple priorities in a fast-paced environment
• Experience in life sciences, medical devices, diagnostics, or pharmaceutical manufacturing environments
• Familiarity with complaint handling and regulatory reporting requirements (e.g., MDR, vigilance reporting)
• Experience with case management or defect tracking systems (e.g., Salesforce, ServiceNow, TrackWise, Jira)
• Lean Six Sigma certification (Green Belt or Black Belt) or equivalent continuous improvement training
• Experience supporting regulatory inspections and audits