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 operation and compliance objectives.
Position Responsibilities
· Support qualification of new Suppliers and Partners for materials and services including risk assessments, audits and other supplier on-boarding activities.
· Provide support to investigation teams in determining root causes on material quality issues and initiate/ensure corrective and preventive action plans are developed and executed.
· Interface with Suppliers/CM (Contract Manufacturer), Engineering/ Manufacturing/ Quality Assurance/ Procurement departments to drive for quality improvements, specifically on incoming rejects, workmanship defects and primitive failures.
· Participate in Quality review activities with supplier/CM to identify improvement opportunities to meet quality expectation.
· Constantly review quality processes and suggests improvements that can be implemented to improve performances.
· Support Supplier/CM development and risk management activities
· Compile, evaluate and report on supplier/CM quality performance metrics for scorecard and monitoring
· Monitor to ensure supplier’s preventive and corrective actions are implemented and effective
· Participate with NPI team in selection of new suppliers
· Other such duties that may be determined by Management
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements
· Experience in directly working with Contract Manufacturer/Suppliers
· Experience in conducting supplier audits.
· Developing basic knowledge of quality tools.
· Beginning to intermediate experience with Microsoft tools and spreadsheets, charting, graphing tools and presentation tools.
· May have experience with electronic production life (PLM), enterprise resource planning tools (SAP) and etc.
· May have experience with statistical analysis packages, eg, JMP, Minitab.
· Must be detailed oriented, well organized and able to work independently and in teams.
· Good communication and collaboration skills
· Ability to travel as needed
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Experience/Education/Skills
· Good understanding of FDA regulatory environment (CFR 820), 501k and ISO 13485 strongly preferred.
· Experience in medical device/ pharmaceutical/ IVD is preferred.
· Typically requires a Bachelor’s Degree in Engineering, Life Sciences, or related field with 0-3 years of experience
