Position Summary
This position is involved in Supplier Quality activities that improve monitor and measure Illuminas 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 suppliers preventive and corrective actions are implemented and effective
Participate with NPI team in selection of new suppliers
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
Typically requires a Bachelors 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
All listed requirements are deemed as essential functions to this position; however business conditions may require reasonable accommodations for additional task and responsibilities.