Quality Assurance Engineer

1 Year ago • All levels • Quality Assurance

Job Summary

Job Description

Illumina is seeking a Quality Assurance Engineer to support new product launches by providing quality control in process verification, validation, design transfer, risk management, and specification development. This role involves sustaining quality operations, including supplier management, quality control processes, and risk management file maintenance. The engineer will collaborate with engineering, QC, and manufacturing teams to improve products and processes through SCAR, NC, CAPA investigations, and ensuring timely resolution of quality issues. Responsibilities include trending and analyzing quality data, collaborating with global teams for supplier performance improvement, and participating in supplier onboarding and qualification activities. The position requires collaboration with global counterparts and cross-functional teams, escalating issues promptly, and reporting status updates to management.
Must have:
  • Experience in supplier management, process quality control, NC and CAPA
  • Strong communication, facilitation, and coaching skills
  • Understanding of GMP and ISO13485
  • 5+ years of QA/QC experience in IVD manufacturing
Good to have:
  • Instrument manufacturing experience
  • Collaboration on teams in multiple/global locations

Job Details

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.
  • Illumina)

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.

Similar Jobs

Blinkhealth - Bilingual Spanish - Customer Support Specialist - On Site

Blinkhealth

Pittsburgh, Pennsylvania, United States (On-Site)
3 Weeks ago
WME IMG - Manager, Marketing

WME IMG

Raleigh, North Carolina, United States (On-Site)
1 Month ago
Rackspace Technology - Principal MLOps Engineer

Rackspace Technology

Toronto, Ontario, Canada (Remote)
3 Months ago
Electronic Arts - Age Ratings Associate Manager

Electronic Arts

Bucharest, Bucharest, Romania (Hybrid)
2 Months ago
Ness - VP/Chief Architect

Ness

New Jersey, United States (Hybrid)
1 Month ago
Scopely - QA Director - Unannounced Project

Scopely

England, United Kingdom (Hybrid)
7 Months ago
Nagarro - Senior QA Automation

Nagarro

(Remote)
2 Months ago
Sony Interactive Entertainment - PlayStation Studios QA Test Support Staff (Part-time)

Sony Interactive Entertainment

Tokyo, Japan (On-Site)
6 Months ago
reality.co - Junior QA - Intern

reality.co

Kraków, Lesser Poland Voivodeship, Poland (On-Site)
1 Month ago
Western Digital - Engineer, Quality Assurance Engineering (FRESH GRAD ONLY)

Western Digital

Phra Nakhon Si Ayutthaya, Thailand (On-Site)
1 Month ago

Get notifed when new similar jobs are uploaded

Similar Skill Jobs

Hitachi - Container Security - Expert

Hitachi

Bengaluru, Karnataka, India (Hybrid)
10 Months ago
Nordson Corporation - Senior Program Manager

Nordson Corporation

Galway, County Galway, Ireland (On-Site)
1 Month ago
extreme network - Sr. Partner Account Manager

extreme network

Texas, United States (Remote)
2 Months ago
sinch  - Lead System Engineer/Team Lead - System & Operations

sinch

Mumbai, Maharashtra, India (On-Site)
1 Month ago
Optiv - Principal Analyst - Threat Hunting

Optiv

Bengaluru, Karnataka, India (On-Site)
1 Month ago
Rippling - Senior Business Development Manager, Services Partnerships

Rippling

San Francisco, California, United States (On-Site)
6 Months ago
endava - Senior Frontend Developer (VueJS)

endava

Kraków, Lesser Poland Voivodeship, Poland (On-Site)
1 Month ago
Devoteam - Senior Security Compliance Consultant

Devoteam

Luxembourg, Luxembourg, Luxembourg (On-Site)
2 Months ago
Palo Alto Networks - Director, Cloud Next Generation Firewall GTM (Global)

Palo Alto Networks

Santa Clara, California, United States (Remote)
2 Months ago
Pay2 - SDET

Pay2

Gurugram, India (On-Site)
2 Months ago

Get notifed when new similar jobs are uploaded

Jobs in Jinhua, Zhejiang, China

Haleon - Business Insight Manager

Haleon

Shanghai, China (On-Site)
1 Month ago
Landor - Client Service Intern

Landor

Shanghai, China (On-Site)
1 Month ago
Microsoft - Researcher

Microsoft

Beijing, Beijing, China (On-Site)
3 Months ago
Cadence - Software Engineering Director

Cadence

Shanghai, China (On-Site)
1 Month ago
MiQ - Sales Manager/Director

MiQ

Guangzhou, Guangdong Province, China (Hybrid)
1 Month ago
Finger Tango - Java Game Development Engineer

Finger Tango

Guangzhou, Guangdong Province, China (On-Site)
1 Year ago
Grab - Data Scientist (Dynamic Pricing)

Grab

Beijing, China (On-Site)
2 Months ago
Monolith - Procurement Manager

Monolith

Shanghai, China (On-Site)
3 Months ago
Tencent - Game Operations (Data Analysis Direction)

Tencent

Shenzhen, Guangdong Province, China (On-Site)
1 Month ago
Thatgamecompany - Senior Graphic Designer

Thatgamecompany

Shanghai, Shanghai, China (On-Site)
3 Months ago

Get notifed when new similar jobs are uploaded

Quality Assurance Jobs

reality.co - Junior QA - Intern

reality.co

London, England, United Kingdom (On-Site)
1 Month ago
Enphase Energy - Sr. Test Technician - 3rd Shift

Enphase Energy

Arlington, Texas, United States (On-Site)
4 Months ago
Qualcomm - Senior Validation Engineer

Qualcomm

Hyderabad, Telangana, India (On-Site)
1 Month ago
playrix  - Lead QA Automation Engineer (Mobile)

playrix

Portugal (Remote)
8 Months ago
Qualcomm - System Hardware Validation Engineer

Qualcomm

Cork, County Cork, Ireland (On-Site)
1 Month ago
bohemia interactive - QA Automation Engineer - DayZ

bohemia interactive

Prague, Prague, Czechia (On-Site)
5 Months ago
binance - Senior QA Engineer (Trading Tech)

binance

Abu Dhabi, Abu Dhabi, United Arab Emirates (Hybrid)
1 Month ago
Nagarro - Staff Engineer, QA Automation

Nagarro

Riyadh, Riyadh Province, Saudi Arabia (On-Site)
8 Months ago
TTC Global - Software QA Engineer (TOSCA exp)

TTC Global

Houston, Texas, United States (On-Site)
2 Months ago
Synechron - QA Automation Engineer

Synechron

Chennai, Tamil Nadu, India (On-Site)
1 Month ago

Get notifed when new similar jobs are uploaded

About The Company

At Illumina, our goal is to apply innovative technologies and revolutionary assays to the analysis of genetic variation and function, making studies possible that were not even imaginable just a few years ago. These studies will help make the realization of personalized medicine possible. With such rapid advances in technology taking place, it is mission critical to have solutions that are not only innovative, but flexible, scalable, and complete with industry-leading support and service. As a global company that places high value on collaborative interactions, rapid delivery of solutions, and prioritizing the needs of its customers, we strive to meet this challenge. Illumina’s innovative, array-based solutions for DNA, RNA, and protein analysis serve as tools for disease research, drug development, and the development of molecular tests in the clinic.



San Diego, California, United States (On-Site)

California, United States (Remote)

San Diego, California, United States (On-Site)

San Diego, California, United States (On-Site)

San Diego, California, United States (Hybrid)

United States (On-Site)

San Diego, California, United States (Hybrid)

View All Jobs

Get notified when new jobs are added by Illumina

Level Up Your Career in Game Development!

Transform Your Passion into Profession with Our Comprehensive Courses for Aspiring Game Developers.

Job Common Plug