Engineer, Computer Software Assurance
BengaluruFull-time5–9 yrsPosted 4 months ago
Senior audit role at Masimo in Bengaluru. Needs 5+ years and a B.Tech, B.E. or B.Sc.
About the role
Engineer, Computer Software Assurance at Masimo. Lead, develop, and execute comprehensive Computer System Validation (CSV) strategies, plans.
What you'll do
- Lead, develop, and execute comprehensive Computer System Validation (CSV) strategies, plans
- Oversee validation activities for GxP-regulated computerized systems including ERP, QMS, MES , manufacturing equipment software, data integrity systems
- Ensure systems meet 21 CFR Part 820, 21 CFR Part 11, and ISO 13485 requirements for software validation and electronic records/electronic signatures
- Partner with cross-functional teams (Quality, IT, Engineering, R&D, Manufacturing) to ensure compliant system lifecycle management aligned with GAMP 5 guidelines
- Drive validation documentation creation, review, and approval, ensuring traceability and regulatory readiness
What you need
- Audit
- Technical writing
- Internal audit
- Compliance
- ISO 9001
- ERP
Good to have
- ISO 27001