Supplier Quality Engineer 2

at  Illumina

What if the work you did every day could impact the lives of people you know? Or all of humanity?
At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.
Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
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.

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.
• 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.

Requirements:

• Some experience in driving suppliers to improve quality performance
• Some experience in conducting supplier audits.
• Good understanding of FDA regulatory environment (CFR 820), 501k and ISO 13485 strongly preferred.
• Experience in medical device/ pharmaceutical/ IVD is preferred.
• 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
• Able to identify components with different colors (using visual)
• 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.

Experience/Education:

• Typically requires a bachelor’s degree in Engineering, Life Sciences, or related field with 0-3 years of experience.

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information

• 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.
• 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 Managemen