Sr. Quality Program Manager, Customer Defect Tracking & Resolution

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. As part of our team youll 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 Fishers 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 Fishers 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)

• Bachelors 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 Belt or Black Belt) or equivalent continuous improvement training.
• Experience supporting regulatory inspections and audits.

Knowledge Skills Abilities

• Strong analytical and problem-solving capabilities with attention to detail.
• Excellent written and verbal communication skills including the ability to communicate complex issues clearly to diverse audiences.
• Ability to assess risk and make sound decisions under pressure.
• Strong organizational skills with the ability to manage multiple high-impact issues simultaneously.
• Demonstrated leadership and influencing skills in a matrixed organization.
• Continuous improvement mindset with a focus on operational excellence and customer satisfaction.
• May require occasional travel (up to 20%).

Our Mission is to enable our customers to make the world healthier cleaner and safer.

As one team of 100000 colleagues we share a common set of values Integrity Intensity Innovation and Involvement working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Manager