Supplier Quality Engineer

Hayward, CA - USA

Monthly Salary: $ 70800 - 106200

Posted on: 16 hours ago

Vacancies: 1 Vacancy

Job Summary

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 thatimprove 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.

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 suppliers preventive and corrective action is implemented and effective
Provide monthly quality data/input for suppliers/CMs 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: $70800 - $106200. 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 individuals 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 To learn more visit: 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.

Required Experience:

What if the work you did every day could impact the lives of people you know Or all of humanityAt 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 t...