Senior Software Quality Engineer

About the role

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.

What you'll do

• Review and approve Software Validation deliverables including but not limited to URS, FS, CS, Risk Assessments, Validation Plans, Test Protocols, Reports
• 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
• Develop and conduct training on Software compliance to software developers, Validation engineers, Software testers and other stakeholders within the organization

What you need

• 5–9 yrs of experience
• SAP
• ISO 9001
• Data modelling
• Machine learning
• B.Tech or B.E. or B.Sc or BCA