Senior Global Supplier Quality Professional II
$104,000–$137,800 year
On-siteWoodbury, Minnesota, United States
Job Summary
Lead global supplier and material governance programs, managing qualification, approval, and lifecycle activities for new suppliers, materials, and components in compliance with quality and regulatory standards. Serve as the primary liaison between suppliers and cross-functional stakeholders to facilitate supplier selection, risk assessment, and ongoing performance management. Oversee supplier change management and quality agreement programs, ensuring all supplier-initiated changes are identified, reviewed, and implemented per QMS and regulatory requirements. Develop, negotiate, and maintain Supplier Quality Agreements while tracking KPIs and analyzing trends to identify emerging risks and drive continuous improvement initiatives. Ensure all activities align with global standards including ISO 13485 and FDA 21 CFR Part 820, supporting internal and external audits. Collaborate with R&D, Regulatory Affairs, and Operations to evaluate supplier risks and facilitate cross-functional decision-making.
Required Qualifications
- Bachelor's degree in life sciences, engineering, or related field
- 8+ years of progressive quality experience in Supplier Quality, Materials Quality, or Quality Systems in a regulated industry
- Experience in medical device, pharmaceutical, or other highly regulated industries
- Demonstrated experience working with global suppliers and cross-regional teams
- Strong knowledge of Quality Management Systems (QMS), materials and supplier controls
- Experience with regulatory standards such as ISO 13485, ISO 9001, FDA 21 CFR Part 820, and/or GMP requirements
- Proficiency in quality tools and methodologies (e.g., FMEA, SPC, process validation, statistical analysis)
- Experience managing vendor change notifications, supplier audits, CAPA systems, and change control processes
- Advanced problem-solving and root cause analysis capabilities
- Strong project management skills with ability to manage multiple initiatives globally
- Excellent communication and stakeholder management skills across technical and non-technical audiences
- Ability to influence without authority and drive accountability across a global supply base
- High level of analytical capability with experience interpreting supplier performance data
- TravelPercentage: 10
Desired Qualifications
- Six Sigma Green/Black Belt
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