Supplier Quality Engineer

Roles & Responsibilities

Position Summary :

This position is responsible for Supplier Quality activities that improve, monitor and measure Illumina's compliance with the Quality System Regulations, Illumina's Quality policies, FDA regulations and ISO standards as well as Illumina product quality requirements for current operational objectives. This role will participate in continuous improvement activities of Illumina's suppliers, purchased parts and purchasing controls.

Position Responsibilities :

• Select new suppliers and partners for material and services
• Lead evaluation and qualification activities of Suppliers providing direct material / service.
• Participate as a core / extended Quality team member of new product development and sustaining teams to assure processes are in place to design and release highly reliable and safe products
• Drive process, quality and product improvements through supplier development activities, risk management, identification and resolution of current and potential issues
• Update purchasing control procedures and processes as needed to stay compliant to quality system requirements and regulations. Provides Quality Assurance expertise and guidance for New Product Development, Manufacturing Operations, Supplier Development, and Product Quality
• Lead purchased material qualification / re-qualification activities such as performance qualification, process validation, first article inspection, measurement gage analysis and capability studies
• Maintain goals and metrics for existing and new products, regularly reporting on the progress to reach departmental objectives
• Lead supplier audits to drive process standardization and continuous improvement
• Identify opportunities for reduced inspection of purchased materials based on risk and quality performance
• Lead and facilitate failure investigations; ensuring mitigations and corrective actions are implemented in a timely manner
• Make recommendations, and drive programs to improve purchased material and supplier performance
• Review non-conformance and SCAR reports to identify actions needed to track and improve program health by site or globally.
• Work with strategic partners and suppliers to ensure global awareness and compliance to procedures and specifications
• Ensure effective