{"id":1540447,"url":"https://alion.io/job/thermo-fisher-scientific-sr-quality-program-manager-customer-defect-tracking-resolution","title":"Sr. Quality Program Manager, Customer Defect Tracking & Resolution","company":{"id":7922,"name":"Thermo Fisher Scientific","domain":"thermofisher.com","url":"https://alion.io/company/thermo-fisher-scientific","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":78,"open_postings":153,"ghost_share":0,"stale_share":0.869,"repost_share":0,"time_to_fill_p50_days":28,"computed_at":"2026-10-21T05:46:15Z"}},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Rochester, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":80000,"max_usd":150000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4487},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"Mandiant capa","optional":false},{"name":"Jira","optional":true},{"name":"ServiceNow","optional":true}],"status":"live","first_seen_at":"2026-08-25T00:00:00Z","employer_posted_date":"2026-08-25","last_verified_at":"2026-10-21T07:16:03Z","board_verified":true,"closed_at":null,"days_open":57,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":57},"description":"Work Schedule\nStandard Office Hours (40/wk) Environmental Conditions\nAdherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob Description\nAt 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.\nThe 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.\nThe 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.\nKey Responsibilities\nQuality & Compliance Leadership\nEnsure all customer defect tracking and resolution activities comply with Thermo Fisher’s QMS, including alignment with CAPA, complaint handling, and escalation processes.\nMaintain compliance with applicable global regulatory requirements (e.g., FDA 21 CFR Part 820/210/211, ISO 13485, ISO 9001, as applicable).\nSupport audit readiness and participate in internal and external audits related to customer complaints and defect management.\nCustomer Issue Intake & Case Management\nLead the daily intake and documentation of customer-reported defects across multiple channels.\nEnsure accurate and complete case creation, including assignment of unique identifiers and proper documentation within approved systems.\nEstablish and maintain standardized severity classification criteria to assess risk and customer impact.\nTriage, Escalation & Prioritization\nEvaluate and triage incoming issues to determine appropriate escalation pathways and urgency.\nAssign severity levels and prioritize cases based on product risk, regulatory impact, and customer criticality.\nDrive immediate response and visibility for high-severity or critical escalations.\nCross-Functional Coordination & Ownership\nAssign case ownership to appropriate functions (e.g., Quality, Manufacturing, R&D, Supply Chain, Customer Support).\nLead cross-functional collaboration to ensure timely investigation, root cause analysis, and resolution.\nTrack progress, ensure accountability, and proactively remove barriers to resolution.\nCommunication & Stakeholder Engagement\nServe as the central point of coordination for customer defect communications.\nEnsure consistent, accurate, and timely communication across internal stakeholders and customer-facing teams.\nConsolidate communications for similar or recurring issues to maintain alignment and clarity.\nProvide regular status updates to leadership and stakeholders on open and critical cases.\nData Analytics & Continuous Improvement\nDevelop and monitor key performance indicators (KPIs), including response time, resolution time, backlog, and recurrence trends.\nAnalyze defect data to identify systemic issues and drive preventive actions.\nPartner with Quality and Engineering teams to implement corrective and preventive actions (CAPA).\nDrive process improvements to enhance efficiency, compliance, and customer experience.\nMinimum Qualifications (Basic Requirements)\nBachelor’s degree in Engineering (Quality, Manufacturing, Mechanical, Industrial, or related discipline).\n7+ years of experience in quality engineering, manufacturing engineering, or a related technical field.\nDemonstrated experience managing customer complaints, defect tracking systems, or escalation processes within a regulated environment.\nStrong knowledge of Quality Management Systems (QMS), including CAPA, root cause analysis (RCA), and risk management tools (e.g., FMEA).\nProven ability to lead cross-functional teams and manage multiple priorities in a fast-paced environment.\nPreferred Qualifications\nExperience in life sciences, medical devices, diagnostics, or pharmaceutical manufacturing environments.\nFamiliarity with complaint handling and regulatory reporting requirements (e.g., MDR, vigilance reporting).\nExperience with case management or defect tracking systems (e.g., Salesforce, ServiceNow, TrackWise, Jira).\nLean Six Sigma certification (Green Belt or Black Belt) or equivalent continuous improvement training.\nExperience supporting regulatory inspections and audits.\nKnowledge, Skills, Abilities\nStrong analytical and problem-solving capabilities with attention to detail.\nExcellent written and verbal communication skills, including the ability to communicate complex issues clearly to diverse audiences.\nAbility to assess risk and make sound decisions under pressure.\nStrong organizational skills with the ability to manage multiple high-impact issues simultaneously.\nDemonstrated leadership and influencing skills in a matrixed organization.\nContinuous improvement mindset with a focus on operational excellence and customer satisfaction.\nMay require occasional travel (up to 20%).\nOur Mission is to enable our customers to make the world healthier, cleaner, and safer.\nAs 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.\n Compensation and Benefits\nThe 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:\nA choice of national medical and dental plans, and a national vision plan, including health incentive programs\n\nEmployee assistance and family support programs, including commuter benefits and tuition reimbursement\n\nAt 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\n\nRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan\n\nEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount\n\nFor more information on our benefits, please visit: 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