Role at a glance
- Job function
-
Manufacturing & Skilled Trades Quality Assurance & Quality Control
- Salary
- Not yet verified Check the description for pay details; an amount or pay period has not been verified.
- Location
- Rochester, New York, United States
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- Senior Level Bachelor’s Degree plus 8-10 years of experience, or Advanced Degree plus 6 years of experience in medical device/pharmaceutical industry quality or regulatory affairs roles Preferred fields of study: Engineering, Operations Management, or Biological Sciences Quality Lead Auditor certification preferred Minimum 3 years people management experience
- Education
- Bachelor’s Degree plus 8-10 years of experience, or Advanced Degree plus 6 years of experience in medical device/pharmaceutical industry...
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Role Summary
The Senior Manager of Supplier Quality leads a team and oversees supplier quality across the supplier lifecycle. The role focuses on supplier risk and compliance, performance improvement, audits, and cross-functional coordination to address supplier quality issues.
What You'll Do
- Lead and develop the Supplier Quality team, including coaching, performance reviews, and talent development.
- Own supplier quality processes from supplier assessment and qualification through ongoing monitoring and improvement.
- Manage supplier risk, regulatory compliance, quality metrics, and supplier audit and corrective-action programs.
- Lead initiatives to address nonconformances, identify root causes, and improve supplier performance and product quality.
- Coordinate with cross-functional partners and supplier leadership to resolve systemic quality challenges.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Requires a bachelor’s degree or advanced degree with the stated industry-quality or regulatory-affairs experience, plus at least 3 years of people management experience. Qualifications include knowledge of ISO 13485 and 21 CFR Part 820; experience with global regulatory agencies, quality management systems, supplier performance, global harmonization, and matrix organizations; Six Sigma and statistical analysis skills; project management and strategic planning; fluent English; and supplier-quality leadership capabilities. The role also requires willingness to travel up to 50%, work in manufacturing environments requiring PPE, and technical proficiency with IT databases and digital tools.
Required
- Bachelor’s Degree plus 8-10 years of experience, or Advanced Degree plus 6 years of experience in medical device/pharmaceutical industry...
- Minimum 3 years people management experience
- Strong knowledge of ISO 13485 and 21 CFR Part 820 regulations
- Experience with global regulatory agencies (FDA, IVDR Notified Bodies, PMDA, ANVISA, Health Canada)
- Proficiency in Six Sigma methodologies (8D, FMEA, DMAIC, Value Stream Mapping, Pareto Analysis)
- Statistical analysis skills (SPC, DOE, sampling)
- Experience with quality management systems (SAP, TrackWise)
- Strong understanding of supplier performance management principles
Preferred
- Preferred fields of study: Engineering, Operations Management, or Biological Sciences
- Quality Lead Auditor certification preferred
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
What will you do?
As a Senior Manager of Supplier Quality, you'll guide our global performance management program and elevate our supplier quality standards. You'll lead a team of Supplier Quality Engineers and work closely with cross-functional partners to support continuous improvement and strategic supplier development. This role offers the opportunity to contribute to critical quality initiatives, develop partnerships with key stakeholders, and facilitate problem-solving activities that address non-conformances.
Key responsibilities include:
· Lead and develop the Supplier Quality team; build talent and succession plans, strengthen organizational capabilities, and manage performance against business priorities.
· Manage team performance through ongoing coaching and formal performance reviews; identify development needs and support individual development plans.
· Own the supplier quality framework across the supplier lifecycle, from initial assessment and qualification through ongoing monitoring and improvement.
· Assist in setting the direction for the Supplier Quality organization, translating business and quality priorities into team objectives, operating plans, and clear accountability.
· Accountable for regulatory compliance and supplier risk management, ensuring risks are assessed, prioritized, and addressed across the supply chain.
· Define supplier quality metrics and review performance trends to guide priorities, resource allocation, new technologies, and process improvements.
· Drive the adoption of technologies and processes that strengthen supplier oversight and support material qualification, product changes, and sustaining engineering.
· Oversee quality improvement programs that deliver measurable gains in supplier performance and product quality.
· Using data analysis, quality tools, project management, and professional skills, lead initiatives to enhance supplier performance and product quality.
· Build strategic alignment across 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 in addressing systemic issues and improving 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, aligning 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.
· Lead continuous improvement projects that improve supplier performance and product quality.
- undefined
How will you get there?
- Bachelor’s Degree plus 8-10 years of experience, or Advanced Degree plus 6 years of experience in medical device/pharmaceutical industry quality or regulatory affairs roles
- Preferred fields of study: Engineering, Operations Management, or Biological Sciences
- Quality Lead Auditor certification preferred
- Minimum 3 years people management experience
- Strong knowledge of ISO 13485 and 21 CFR Part 820 regulations
- Experience with global regulatory agencies (FDA, IVDR Notified Bodies, PMDA, ANVISA, Health Canada)
- Proficiency in Six Sigma methodologies (8D, FMEA, DMAIC, Value Stream Mapping, Pareto Analysis)
- Statistical analysis skills (SPC, DOE, sampling)
- Experience with quality management systems (SAP, TrackWise)
- Strong understanding of supplier performance management principles
- Excellence in oral and written communication, with 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/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 with experience implementing effective solutions
- Manage a team and provide leadership and accountability for team performance, workload prioritization, management reviews, escalated supplier risks, supplier governance cadence, KPI targets, talent development, and execution of the supplier quality strategy.
- Execute on cross-division harmonization and organizational capabilities.
- Experience working with commodities ranging from machined parts, electrical components, plastics, resin, chemicals
Compensation and Benefits
The salary range estimated for this position based in New York is $119,400.00–$165,000.00.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
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.