Sr. Quality Program Manager, Customer Defect Tracking & Resolution

Key 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.

Minimum Qualifications (Basic 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.

Preferred Qualifications

• 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).
• Lever Six Sigma certification (Green Belt or Black Belt) or equivalent continuous improvement training.
• Experience supporting regulatory inspections and audits.
• Knowledge of defect data analytics and continuous improvement.