Sr Manager, Supplier Quality

Thermo Fisher Scientific•Rochester, NY
•$119,400 - $165,000•Onsite

About The Position

As a Senior Manager of Supplier Quality at Thermo Fisher Scientific, you will guide the global supplier performance management program and elevate supplier quality standards. You will lead a team of Supplier Quality Engineers and work with cross-functional partners on continuous improvement, strategic supplier development, quality initiatives, stakeholder partnerships, and problem-solving related to non-conformances. The role owns the supplier quality framework across the supplier lifecycle, including assessment, qualification, monitoring, and improvement, and is accountable for regulatory compliance and supplier risk management. It also leads supplier audits, corrective action governance, supplier performance improvement, and quality initiatives aligned with business priorities. The position is based in an office environment, follows a standard Monday–Friday schedule, may require travel up to 50% domestically and internationally, and may involve manufacturing environments requiring PPE, including cleanroom gear. The role requires a bachelor’s degree plus 8–10 years of relevant experience, or an advanced degree plus 6 years of relevant experience in medical device or pharmaceutical industry quality or regulatory affairs. A minimum of 3 years of people management experience is required. Preferred fields of study are Engineering, Operations Management, or Biological Sciences. A Quality Lead Auditor certification is preferred. The position offers an estimated New York salary range of $119,400–$165,000 and may be eligible for a variable annual bonus. Benefits include medical, dental, and vision plans; health incentive programs; employee assistance and family support programs; commuter benefits; tuition reimbursement; paid time off and holidays; paid parental leave; accident and life insurance; short- and long-term disability; retirement and savings programs including a 401(k); and an employee stock purchase plan.

Requirements

  • Bachelor’s degree plus 8–10 years of experience, or an advanced degree plus 6 years of experience, in medical device or pharmaceutical industry quality or regulatory affairs roles.
  • At least 3 years of people management experience.
  • Strong knowledge of ISO 13485 and 21 CFR Part 820 regulations.
  • Experience with global regulatory agencies, including FDA, IVDR Notified Bodies, PMDA, ANVISA, and Health Canada.
  • Proficiency in Six Sigma methodologies, including 8D, FMEA, DMAIC, Value Stream Mapping, and Pareto Analysis.
  • Statistical analysis skills, including SPC, DOE, and sampling.
  • Experience with quality management systems such as SAP and TrackWise.
  • Strong understanding of supplier performance management principles.
  • Excellent oral and written communication skills and fluency in English.
  • Experience implementing global harmonization initiatives.
  • Experience managing matrix organizations across diverse cultures.
  • Strong project management and strategic planning capabilities.
  • Ability to build and maintain relationships with internal and external stakeholders.
  • Willingness to travel up to 50% domestically and internationally.
  • Ability to work in manufacturing environments requiring PPE, including cleanroom gear.
  • Technical proficiency with IT databases and digital tools.
  • Problem-solving mindset and experience implementing effective solutions.
  • Experience working with commodities including machined parts, electrical components, plastics, resin, and chemicals.

Nice To Haves

  • Preferred field of study in Engineering, Operations Management, or Biological Sciences.
  • Quality Lead Auditor certification.

Responsibilities

  • Lead and develop the Supplier Quality team, including talent and succession planning, capability development, performance management, coaching, formal reviews, and individual development plans.
  • Set direction for the Supplier Quality organization and translate business and quality priorities into team objectives, operating plans, and accountability.
  • Own the supplier quality framework throughout the supplier lifecycle, from assessment and qualification through monitoring and improvement.
  • Ensure regulatory compliance and manage supplier risks by assessing, prioritizing, and addressing risks across the supply chain.
  • Define supplier quality metrics and review performance trends to guide priorities, resource allocation, technology adoption, and process improvement.
  • Drive technologies and processes that strengthen supplier oversight and support material qualification, product changes, and sustaining engineering.
  • Oversee quality improvement programs and lead initiatives that produce measurable gains in supplier performance and product quality.
  • Build strategic alignment with Sourcing, Manufacturing, Product Engineering, Global Technical Support, Operations, and Commodity Management to resolve systemic supplier quality challenges.
  • Develop senior-level supplier relationships and engage supplier leadership to address systemic issues and improve supplier quality capability.
  • Plan and lead supplier quality audits, document findings, and follow up on corrective actions.
  • Own the supplier audit program and corrective action governance, ensuring findings are addressed and recurring issues are prevented.
  • Oversee the supplier nonconformance and corrective action system, ensuring timely containment, effective root cause analysis, and sustained corrective and preventive actions.
  • Guide continuous improvement priorities across the supplier network and align projects and resources with business needs and quality risks.
  • Maintain and analyze supplier quality and performance metrics to identify trends, investigate non-conformances, and conduct root cause analysis.
  • Manage workload prioritization, management reviews, escalated supplier risks, supplier governance cadence, KPI targets, talent development, and execution of the supplier quality strategy.
  • Execute cross-division harmonization and develop organizational capabilities.

Benefits

  • Choice of national medical and dental plans and a national vision plan, including health incentive programs.
  • Employee assistance and family support programs.
  • Commuter benefits.
  • Tuition reimbursement.
  • At least 120 hours of paid time off (PTO).
  • 10 paid holidays annually.
  • Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
  • Accident and life insurance.
  • Short- and long-term disability in accordance with company policy.
  • Competitive 401(k) U.S. retirement savings plan and other retirement and savings programs.
  • Employee Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
  • Potential eligibility for a variable annual bonus based on company, team, and/or individual performance results.
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