Work ScheduleStandard Office Hours (40/wk)
Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job DescriptionThe 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 ResponsibilitiesQuality & 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 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%).
Compensation and BenefitsThe salary range estimated for this position based in New York is $118,100.00-$177,200.00.
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: https://jobs.thermofisher.com/global/en/total-rewards
