Quality Assurance Engineer

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 Responsibilities:

• Provide quality support in the areas of process control, process verification and validation, design transfer, risk management, and specification development for new product launch.
• Responsible for sustaining quality operation activities including Quality Control Process, Risk Management File, Supplier Management Procedures establish and optimization, support and review product/process/supplier related requests for change.
• Collaborate with engineering, QC, MFG team to improve product&process by driving SCAR, both MFG and Supplier Related NC, Quality Investigation and CAPA investigation. Ensure product disposition and quality Issue could resolve in time.
• Trend, analyze and report MFG and supplier related quality data to improve product and process, collaborate with Global team for supplier quality performance review and improvement
• Involved in supplier onboard, collaborate with purchasing team for supplier quality agreement sign-off. Lead or review supplier material qualification activities, eg. Material/Component specification discussion, process validation, FAI or supplier audit.
• Provide management with status update and escalate issues in a timely manner
• Collaborate with counterparts and cross-functional teams at other Illumina sites.
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All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Preferred Education:

Bachelor’s degree in biochemical engineering/mechanical/electrical engineering

Preferred Requirements:

• 5+ years of relevant experience of quality assurance/ quality control experience in IVD manufacturing environment, instrument MFG experience is preferred.
• Practical experience of in supplier management, process quality control, NC and CAPA
• Highly effective communication, facilitation and coaching skills, collaboration on teams in multiple/global locations is desired.
• Good understanding of GMP and ISO13485.

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.