Senior Supplier Quality Engineer

About This Role

Senior Supplier Quality Engineer at Illumina interfaces with suppliers to ensure GMP compliance, manage risk assessments and audits, and provide feedback on supplier performance.

Responsibilities

• Assess unusual circumstances and suggest variations in approach to solve problems.
• Work on assignments with limited information, adapting existing techniques for diverse scope.
• Enhance internal and external working relationships with senior partners within expertise areas.
• Adapt style to differing audiences and advise on difficult matters requiring persuasion.
• Work independently at critical review points using evaluation, judgment, and interpretation to select best course of action.
• Apply core knowledge of FDA 21 CFR Part 820, ISO 13485, and supplier management processes.

Requirements

• Familiarity with FDA 21 CFR Part 820, ISO 13485, and supplier management processes.
• Practical application of Problem Solving (CAPA/SCAR), Risk Management (FMEA), Non-conformance Handling, and continuous improvement tools.
• Strong cross-functional collaboration, negotiation, and communication skills to manage relationships internally and externally.
• Willingness to travel domestically and internationally as required (typically around 25%).