Engineer, Computer Software Assurance
BengaluruFull-time5–9 yrsPosted 4 weeks ago
Senior audit role at Beckman Coulter in Bengaluru. Needs 5+ years.
About the role
The Engineer, Computer Software Assurance is responsible for ensuring that computerized systems used in GxP processes at Masimo comply with global regulatory requirements. This role provides strategic oversight of CSV activities across the organization, ensuring compliance with FDA, ISO, and global regulations while enabling efficient and robust system implementations.
What you'll do
- Responsible for ensuring that computerized systems used in GxP processes at Masimo comply with global regulatory requirements
- 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
What you need
- ISO 9001
- ISO 27001
- Compliance
- ERP
- Audit
- Technical writing