Supplier Quality Manager
On-site · Caledonia, Michigan, United States
Job Summary
Lead and govern the global supplier quality program for Aspen’s medical device operations, owning qualification, onboarding, performance management, audits, and continuous improvement, while managing a growing team of SQEs. Direct accountability for finished goods supplier quality at the Caledonia, MI Distribution Center. Drive alignment with FDA QMSR and ISO 13485, maintain ASL and supplier scorecards, conduct supplier audits and SCAR processes, support NPD and M&A integrations, and ensure regulatory readiness and continuous improvement across the enterprise.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related field
- Minimum of 7–10 years of quality experience in a medical device or regulated manufacturing environment
- At least 3–5 years in a supplier quality role
- Strong working knowledge of FDA’s QMSR, ISO 13485, and ISO 9001
- Demonstrated experience conducting supplier audits, managing SCARs, and driving supplier performance improvement
- Experience managing supplier qualification programs, Approved Supplier Lists, audit programs and supplier evaluation systems
- Leadership experience including direct employee leadership and influential organizational leadership for site resources
- Solid understanding of quality tools and methodologies including FMEA, root cause analysis, CAPA, control plans, and statistical sampling
- Willingness to travel up to 25% (domestic and international)
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