Senior Supplier Quality Engineer

Responsibilities

• Interface with development and supplier engineering to provide materials and components for product manufacturing.
• Communicate product specifications to suppliers and assess their ability to meet engineering and quality requirements.
• Evaluate supplier internal functions to assess overall performance and provide feedback on operations.
• Qualify suppliers according to company standards and administer Certified Supplier Programs where applicable.
• Monitor parts from acquisition through the manufacturing cycle and resolve supplier-related problems.
• Develop and prioritize an auditing schedule to ensure suppliers meet Good Manufacturing Practices (GMP) and quality standards.
• Apply sophisticated analytical and problem-solving techniques to identify causes and suggest variations in approach for complex issues.

Requirements

• Familiarity with FDA 21 CFR Part 820 and ISO 13485.
• Practical application of Problem Solving (CAPA/SCAR), Risk Management (FMEA), and Non-conformance Handling.
• Strong cross-functional collaboration, negotiation, and communication skills.
• Willingness to travel domestically and internationally (typically around 25%).

Preferred Qualifications

• Bachelor's or master's degree in Engineering, Life Sciences, or a related field.
• Minimum 3 years of experience specifically as a Supplier Quality Engineer or in a closely related supplier relationship function.
• Demonstrated track record in component qualification, vendor audits, and supplier risk assessments.
• Deep understanding of First Article Inspection (FAI) and Mistake Proofing.

About the Company

Illumina is expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.