Bengaluru, Karnataka, India · On-site
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 worl…
Skills: Software Quality Engineering, Software Validation, Risk Management, Regulatory Compliance, SDLC
Bengaluru, Karnataka, India · On-site
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 worl…
Skills: Software Quality Engineering, SDLC, Risk Management, Verification and Validation, Regulatory Compliance
Bengaluru, Karnataka, India · On-site
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 worl…
Skills: Software Quality Engineering, SDLC, Risk Management, Regulatory Compliance, Verification and Validation
San Diego, California, United States · On-site
$27/hr–$41/hr
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 worl…
Skills: Equipment Maintenance, Troubleshooting, Preventive Maintenance, Corrective Maintenance, Optical Systems
San Diego, California, United States · On-site
$68k–$103k/yr
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 worl…
Skills: Equipment Reliability, Preventive Maintenance, Troubleshooting, Calibration, Optical Systems
San Diego, California, United States · On-site
$98k–$148k/yr
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 worl…
Skills: Compliance Engineering, EMC Testing, EMI Testing, RF Exposure, Regulatory Compliance
Singapore, Singapore · On-site
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 worl…
Skills: Project Management, Facilities Engineering, ACMV, Mechanical Systems, Electrical Systems
Bengaluru, Karnataka, India · On-site
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 worl…
Skills: SAP ERP, S/4HANA, IT Leadership, Enterprise Applications, SAP Architecture
Singapore, Singapore · On-site
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 worl…
Skills: Process Improvement, Warehouse Operations, Logistics Management, SAP, SQL
San Diego, California, United States · On-site
$118k–$177k/yr
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 worl…
Skills: AI Enablement, Supply Chain Management, Generative AI, Agentic AI, RPA
Eindhoven, North Brabant, Netherlands · On-site
$52k–$79k/yr
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 worl…
Skills: Trade Compliance, Import/Export Regulations, Customs Requirements, Sanctions Frameworks, Tariff Classification
Cambridge, England, United Kingdom · Hybrid
$111k–$166k/yr
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 worl…
Skills: Regulatory Legal Advisory, Medical Device Regulation, IVDR, Life Sciences Law, Risk Assessment
Singapore, Singapore · On-site
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 worl…
Skills: PLM Configuration, Change Management, BOM Management, Document Control, ERP Systems
Eindhoven, North Brabant, Netherlands · On-site
$33k–$50k/yr
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 worl…
Skills: Warehouse Leadership, Material Handling, Logistics Management, Team Coaching, Inventory Integrity
Bengaluru, Karnataka, India · On-site
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 worl…
Skills: Generative AI, RAG Architectures, Python, Java, Spring Boot
Bengaluru, Karnataka, India · On-site
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 worl…
Skills: React, TypeScript, LLM Integration, Prompt Engineering, Next.js
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Lead and support quality and compliance activities for non-product software used in the Quality Management System and manufacturing processes. Ensure systems are verified, validated, and compliant with regulatory requirements such as 21CFR820 and ISO 13485.
Requires a Bachelor's degree in Computer Science or a related field and over 5 years of experience in software quality engineering within a regulated medical device industry. Proficiency in SDLC processes and industry standards like 21 CFR and ISO 13485 is essential.
We are seeking a Senior Software Quality Engineer to lead and support quality and compliance activities for Non-Product Software used in support of the Quality Management System (QMS) and Software used in the manufacture process of Illumina’s products.
The Senior Software Quality Engineer ensures the software and systems are verified, validated, maintained, and compliant with applicable regulatory requirements (21CFR820, 21CFR11), International Standards (ISO 13485), standards/guidance (TR80002-2, CSA, General Principles of Software Validation), and company procedures.
All listed tasks and responsibilities are deemed essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.
Unlocking the Power of the Genome
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.
Offices: 5200 Illumina Way, San Diego, CA 92122, US · 524 Genomic Dr, Madison, Wisconsin 53719, US · 9440 Carroll Park Dr, San Diego, CA 92121, US · 10 Biopolis Rd, Singapore, Singapore 138670, SG · 200 Lincoln Centre Dr, Foster City, California 94404, US
Unlocking the Power of the Genome
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.
Offices: 5200 Illumina Way, San Diego, CA 92122, US · 524 Genomic Dr, Madison, Wisconsin 53719, US · 9440 Carroll Park Dr, San Diego, CA 92121, US · 10 Biopolis Rd, Singapore, Singapore 138670, SG · 200 Lincoln Centre Dr, Foster City, California 94404, US
