Sr. Quality Program Manager, Customer Defect Tracking & Resolution

Regulatory Toolkit; City of Rochester (NY); On-site; USD 118,000 - 177,000; Full time

Benefits offered by this job

Medical, dental, and vision plans

Paid time off (PTO) and holidays

Parental leave and life insurance

401(k) retirement plan

Employee stock purchase plan

Tuition reimbursement

Job summary

Thermo Fisher Scientific in New York is seeking a Sr. Quality Program Manager to lead global customer defect tracking and resolution.

You will ensure a robust, compliant process aligned with QMS and regulatory requirements, driving cross-functional collaboration and timely issue resolution. You will guide intake, triage, escalation, and communications for customer defects, enabling continuous improvement and CAPA execution across multiple functions.

Qualifications

• Bachelor’s degree in Engineering field.
• 7+ years of experience in quality or manufacturing engineering.
• Experience managing customer complaints or defect tracking in regulated environments.
• Strong knowledge of QMS, CAPA, RCA, and risk management tools.
• Proven ability to lead cross-functional teams in fast-paced settings.

Responsibilities

• Ensure defects tracking aligns with QMS, CAPA, complaints and escalation.
• Maintain compliance with FDA/ISO regulatory requirements.
• Support audits related to customer complaints and defect management.
• Lead daily intake and documentation of customer-reported defects.
• Assign case ownership and maintain documentation in approved systems.
• Develop severity criteria and prioritize cases.
• Coordinate cross-functional ownership and timely investigations.
• Provide status updates to leadership.
• Develop KPIs and drive CAPA-driven improvements.

Skills

Quality engineering

CAPA & RCA

QMS knowledge

Cross-functional leadership

Regulatory compliance

Project management

Education

Bachelor's degree in Engineering

Tools

Salesforce

ServiceNow

TrackWise

Jira

Job description

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 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 100,000+ 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

The 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