Staff Supplier Quality Engineer

What if the work you did every day could impact the lives of people you know? Or all of humanity?

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At Illumina, we are 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.

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Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

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Position Summary

This position is involved in Supplier Quality activities that improve, monitor and measure Illumina's compliance with the Quality System Regulations, Illumina Quality policies, FDA regulations and ISO standards, as well as Illumina product quality for current operations and compliance objectives.

Responsibilities

• Lead activities to improve material quality from suppliers, including corrective and preventive actions to ensure non-conforming parts do not enter Illumina.
• Manage and develop long-term supplier relationships with key sub-assembly suppliers to build their capability to meet Illumina's quality requirements and expectations.
• Initiate supplier improvement projects, including: Process analysis Value stream mapping Process capability analysis Throughput analysis Six Sigma 5S Kaizen events
• Actively manage suppliers to ensure there are no regressions following implementation of new processes.
• Establish short-term and long-term supplier quality goals.
• Drive timely resolution of supplier quality issues to ensure continuity of supply.
• Assist in the evaluation and qualification of new suppliers and materials following the defined new product development process.
• Drive a "Zero Defect" mentality within the supply base.
• Develop new suppliers to meet Illumina's quality and regulatory requirements and guide suppliers from conditional to acceptable status through improvement actions.
• Ensure supplier performance is regularly reported and appropriate corrective actions are implemented in a timely manner.
• Conduct supplier audits to verify compliance with QMS regulatory requirements, effective process controls, and Illumina requirements.
• Monitor, communicate, and improve key Supplier Quality metrics, including: SCAR Past Due KSPM Score Assembly Yield
• Travel to supplier locations to resolve quality problems.

Preferred Requirements

• 8+ years of experience in a quality assurance field within a regulated environment; experience in IVD manufacturing preferred.