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Senior Software Quality Engineer
Illumina
Bengaluru, IND
Full-time
Senior · 5+ years experience
Onsite
Discovered 3 weeks ago
CamstarLIMSSAPETQAI/MLCloud
Free
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Role Overview
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.
Key Skills for This Role
CamstarLIMSSAPETQAI/MLCloud
Full Job Posting
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 Software compliance to software developers, Validation engineers, Software testers and other stakeholders within the organization
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