Senior Manager Supplier Quality
Core
Lead supplier quality assurance activities for Third Party Manufacturers (TPMs) and suppliers to ensure compliance with regulatory requirements and quality standards.
Role type
Senior Manager, Supplier Quality Assurance
Builds
Safe, effective, and compliant product supply for diabetes care devices
Domain
Medical devices / Diabetes care / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier quality management, Regulatory compliance (FDA QSR, ISO 13485), Team leadership, Quality system procedures, Validation strategies, Corrective and preventive action planning, Budget management, Cross-functional stakeholder engagement
Preferred skills
Design Controls, Verification & Validation (V&V), Manufacturing operations, Statistical analysis tools, Professional certifications (CQE, CQA, CQM)
Technologies
Microsoft Office, Quality/statistical analysis tools
Responsibilities
Provide strategic leadership for supplier quality assurance across TPMs and suppliers; Lead and develop a team of Supplier Quality Engineers; Monitor supplier performance and communicate quality trends to senior leadership; Develop and maintain supplier quality management review programs; Act as primary reviewer for significant TPM exception documents; Drive supplier continuous improvement initiatives; Evaluate and approve supplier-initiated changes (new suppliers, alternate materials, process changes); Provide expert QA guidance on validation strategies; Serve as Subject Matter Expert during audits and inspections; Manage Supplier Quality budgets.
Seniority
Senior Manager, hands-on leadership with team management