Sr. Supplier Quality Engineer

The Senior Supplier Quality Engineer is responsible for supporting the Supplier Quality organization by overseeing components, materials, and services provided by suppliers. This role ensures that suppliers meet all regulatory and quality requirements, collaborates with internal teams, and drives continuous improvement in supplier performance.

Requirements

• Working knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation (as applicable), cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001
• Quality System Regulation and risk management
• Validations (IQ, OQ, PQ) and root cause analysis (CAPA process)
• Project management techniques
• Measurement system analysis (GR&R, AAA)
• Statistical Process Controls (SPC) and statistical sampling
• PPAP (Production Part Approval Process) knowledge (desirable)
• Familiarity with applicable regulations (FDA, Canada, Brazil, Japan, etc.)
• Effective written and verbal communication at all organizational levels
• Proficiency in problem-solving tools (SPC, TQM, etc.)
• Analytical skills to evaluate data and situations, translating them into actionable plans
• Ability to communicate ideas and approaches through proposals, plans, and presentations
• High proficiency with Microsoft Office suite for reporting and data analysis
• Ability to manage multiple complex projects simultaneously
• Ability to work independently and collaboratively
• ISO 13485 lead auditor certification (preferred)
• Proficiency in English (written and oral); a second language is a plus
• Familiarity with tools such as Project, Visio, MiniTab, and Agile (desirable)