About the role

AI summarised

The Supplier Quality Engineer 2 supports supplier qualification, monitors supplier quality performance, and drives improvements through audits, root cause analysis, and corrective actions. The role involves cross-functional collaboration with engineering, manufacturing, quality, and procurement teams to ensure compliance with FDA regulations, ISO standards, and Illumina’s quality system. Occasional travel (up to 25%) is required to engage with suppliers and contract manufacturers.

BiotechOnsite

Key Responsibilities

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

Requirements

Typically requires a Bachelor’s Degree in Engineering, Life Sciences, or related field with 2-5 years of relevant experience
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
Good understanding of FDA regulatory environment (CFR 820), 501k and ISO 13485 strongly preferred
Experience in medical device/ pharmaceutical/ IVD is preferred
Ability to travel as needed, estimated around 25% of the time