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Engineer, Computer Software Assurance

Masimo·Bengaluru

Pay not stated5–9 yrsFull-time
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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

  • 5–9 yrs of experience
  • Audit
  • Technical writing
  • Internal audit
  • Compliance
  • ISO 9001
  • ERP
  • B.Tech or B.E. or B.Sc or BCA

Good to have

  • ISO 27001

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