[Remote] Sr. Quality Program Manager, Customer Defect Tracking & Resolution

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.ResponsibilitiesEnsure all customer defect tracking and resolution activities comply with Thermo Fisher’s QMS, including alignment with CAPA, complaint handling, and escalation processesMaintain 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 managementLead the daily intake and documentation of customer-reported defects across multiple channelsEnsure accurate and complete case creation, including assignment of unique identifiers and proper documentation within approved systemsEstablish and maintain standardized severity classification criteria to assess risk and customer impactEvaluate and triage incoming issues to determine appropriate escalation pathways and urgencyAssign severity levels and prioritize cases based on product risk, regulatory impact, and customer criticalityDrive immediate response and visibility for high-severity or critical escalationsAssign 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 resolutionTrack progress, ensure accountability, and proactively remove barriers to resolutionServe as the central point of coordination for customer defect communicationsEnsure consistent, accurate, and timely communication across internal stakeholders and customer-facing teamsConsolidate communications for similar or recurring issues to maintain alignment and clarityProvide regular status updates to leadership and stakeholders on open and critical casesDevelop and monitor key performance indicators (KPIs), including response time, resolution time, backlog, and recurrence trendsAnalyze defect data to identify systemic issues and drive preventive actionsPartner with Quality and Engineering teams to implement corrective and preventive actions (CAPA)Drive process improvements to enhance efficiency, compliance, and customer experienceSkillsBachelor's degree in Engineering (Quality, Manufacturing, Mechanical, Industrial, or related discipline)7+ years of experience in quality engineering, manufacturing engineering, or a related technical fieldDemonstrated experience managing customer complaints, defect tracking systems, or escalation processes within a regulated environmentStrong 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 environmentExperience in life sciences, medical devices, diagnostics, or pharmaceutical manufacturing environmentsFamiliarity 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 trainingExperience supporting regulatory inspections and auditsBenefitsVariable annual bonus based on company, team, and/or individual performance results in accordance with company policyA choice of national medical and dental plans, and a national vision plan, including health incentive programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt 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 policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discountCompany OverviewThermo 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.