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
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. 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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants.
