Sr. Quality Program Manager, Customer Defect Tracking & Resolution

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. As part of our team, you’ll help enable our customers to make the world healthier, cleaner, and safer.

The Sr. Quality Program Manager, Customer Defect Tracking & Resolution will lead the global intake, triage, tracking, escalation, and communication of customer-reported defects and quality issues. This role is responsible for ensuring a robust, compliant, and scalable process aligned with Thermo Fisher’s Quality Management System (QMS), applicable regulatory requirements (e.g., FDA, ISO), and customer expectations.

The successful candidate will bring strong technical expertise in quality or manufacturing engineering, combined with leadership capabilities to drive cross-functional collaboration, timely issue resolution, and continuous improvement.

Key Responsibilities

Quality & Compliance Leadership

• 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.

Customer Issue Intake & Case 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.

Triage, Escalation & Prioritization

• 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.

Cross-Functional Coordination & Ownership

• 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.

Communication & Stakeholder Engagement

• 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.

Data Analytics & Continuous Improvement

• 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).
• Lean Six Sigma certification (Green B