Sr. Supplier Quality Engineer I

Tandem Diabetes Care seeks a Senior Supplier Quality Engineer to oversee supplier audits, qualify new suppliers, and monitor supplier performance in a regulated medical device environment. The role combines independent supplier management with cross-functional collaboration to ensure quality standards and continuous improvement.

Responsibilities

• Lead and oversee supplier audits to meet company, quality, and regulatory requirements
• Generate, review, and monitor supplier CAPA plans through investigation and closure
• Qualify, manage, and monitor supplier performance per established processes
• Provide guidance to suppliers on quality disciplines including PFMECA, DMAIC, and DOE
• Report quality trends and supplier performance metrics to management

Requirements

• Direct experience managing suppliers and contract manufacturers in regulatory environments
• Proficiency in ISO 13485, ISO 14971, ISO 9001, and GMP standards
• Competency in QMS and process audit practices with non-conformance recognition
• Strong statistical knowledge including sampling theory, capability analysis, and SPC
• Proficiency in problem-solving methodologies and mechanical drawing interpretation
• Bachelor's degree in Engineering or equivalent experience preferred
• ISO lead auditor certification or CQE preferred; 5+ years supplier quality experience