Staff Supplier Quality Engineer

About the role

Illumina is hiring a Staff Supplier Quality Engineer to lead supplier quality activities that improve, monitor and measure compliance with the Quality System Regulations, Illumina's quality policies, FDA regulations and ISO standards, as well as product quality for current operations. The role drives supplier quality improvement, manages supplier relationships and ensures continuity of supply.

Key responsibilities

• Lead activities to improve material quality from suppliers, including corrective and preventive actions so non-conforming parts do not enter Illumina.
• Manage and develop long-term relationships with key sub-assembly suppliers and initiate improvement projects such as process analysis, value stream mapping, process capability and throughput analysis, Six Sigma, 5S and Kaizen events.
• Establish supplier quality goals, drive timely resolution of quality issues and ensure supplier performance is reported with corrective actions implemented.
• Assist in evaluating and qualifying new suppliers and materials, and develop new suppliers from conditional to acceptable status.
• Conduct supplier audits and travel to supplier locations to resolve quality problems.
• Monitor and improve key metrics such as SCAR, past due KSPM score, assembly yield and drive a "Zero Defect" mentality.

Required profile

• 8+ years of experience in a quality assurance field in a regulated environment; IVD manufacturing experience preferred.
• Preferred: quality certification such as CQE.
• Typically a minimum of 8 years of related experience with a Bachelor's degree, or 6 years with a Master's, or 3 years with a PhD, or equivalent.
• Able to work internationally and independently with minimal supervision.

Required skills

• Quality regulations and standards: 21 CFR 820, ISO 13485, ISO 14971, IVDD, ISPE Baseline Guides, ASTM E2500-07.
• Design controls, risk management, validation, change control and supplier quality.
• CAPA and failure investigation tools.
• Statistical tools: SPC, Six Sigma, risk analysis, FMEA, DOE, trend analysis.