Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a leading company in the healthcare industry, dedicated to enabling customers to make the world healthier, cleaner, and safer. They are seeking a Sr. Quality Program Manager to lead the global intake, triage, tracking, escalation, and communication of customer-reported defects and quality issues, ensuring compliance with their Quality Management System and regulatory standards.
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
Skills
- 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
- 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
Benefits
- Variable annual bonus based on company, team, and/or individual performance results in accordance with company policy
- 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
Company Overview
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services. It was founded in 1956, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 10001+ employees. Its website is https://www.thermofisher.com.