Sr Manager, Supplier Quality

Key Responsibilities

• 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.

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