Supplier Quality Engineer

The Supplier Quality Engineer at Illumina is responsible for ensuring compliance with Quality System Regulations, FDA regulations, and ISO standards, as well as maintaining Illumina product quality. This role involves leading investigations into material quality issues, driving corrective actions with suppliers and contract manufacturers, and continuously improving quality processes. The engineer will also manage supplier qualifications, evaluate performance metrics, and collaborate with procurement and engineering teams to identify new suppliers.

Must Have

• Lead or support investigations to determine root causes on material quality issues and initiate/ensure corrective and preventive action plans are developed and executed.
• Interface with Suppliers/CM, Engineering/Manufacturing/Quality Assurance/Procurement departments to drive for quality improvements.
• Drive Quality review with supplier/CM for improvement to meet quality expectation.
• Constantly review quality processes and suggest improvements.
• Manage Supplier/CM through continuous improvement activities.
• Compile and evaluate supplier/CM quality performance metrics.
• Ensure that supplier’s preventive and corrective action is implemented and effective.
• Provide monthly quality data/input for suppliers/CM’s Scorecard.
• Responsible for the qualification processes for suppliers, including new supplier evaluation, audit programs and supplier approval programs.
• Work closely with Procurement and Engineering departments to identify new suppliers for evaluation.
• Experience in managing Contract Manufacturer/Suppliers.
• Experience in conducting supplier audits.
• Good understanding of FDA regulatory environment (CFR 820), 501k and ISO 13485.
• Developing basic knowledge of FDA Quality System Regulations and/ or ISO 13485 Standard.
• Developing basic knowledge of quality tools.
• Beginning to intermediate experience with words processing and spreadsheets, charting, graphing tools and presentation tools.

Good to Have

• Experience in medical device/ pharmaceutical/ IVD.
• Experience with electronic production life (PLM), enterprise resource planning tools (SAP).
• Experience with statistical analysis packages, eg, JMP, minitab.

Perks & Benefits

• Access to genomics sequencing
• Family planning
• Health/dental/vision benefits
• Retirement benefits
• Paid time off

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 responsible for 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:

• Lead or provide support to investigations to determine 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.
• Drive Quality review with supplier/CM for improvement to meet quality expectation.
• Constantly review quality processes and suggests improvements that can be implemented to improve performances.
• Manage Supplier/CM through continuous improvement activities.
• Compile and evaluate supplier/CM quality performance metrics.
• Ensure that supplier’s preventive and corrective action is implemented and effective
• Provide monthly quality data/input for suppliers/CM’s Scorecard.
• Responsible for the qualification processes for suppliers, including new supplier evaluation, audit programs and supplier approval programs
• Work closely with Procurement and Engineering departments to identify new suppliers for evaluation.
• May be involved in providing training.
• 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:

• Experience in managing Contract Manufacturer/Suppliers
• 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 FDA Quality System Regulations and/ or ISO 13485 Standard.
• Developing basic knowledge of quality tools.
• Beginning to intermediate experience with words processing 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.

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 B.S. degree and 0 to 2 years of experience, or additional experience in lieu of degree.

The estimated base salary range for the Supplier Quality Engineer role based in the United States of America is: $70,800 - $106,200. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

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. This role is not eligible for visa sponsorship.