Senior Software Quality Engineer

Illumina — India - Bengaluru - Manyata

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: 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. Tasks and Responsibilities: Review and approve Software Validation deliverables including but not limited to URS, FS, CS, Risk Assessments, Validation Plans, Test Protocols, Reports, change control, etc. to ensure compliance with regulatory requirements. Lead Software assessments, classification and categorization. Ensure validation activities for Non-Product Software follow applicable regulations (e.g., 21CFR820 and 21CFR11) identifying areas and opportunities to improve. Lead software risk management activities for non-product software (NPSW), including software used in support of manufacturing processes (Camstar, LIMS, etc.) and Quality System Software (SAP, ETQ, etc.) Develop and conduct training on Soft

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