23 Aug
|
Baxter India
|
Bengaluru
23 Aug
Baxter India
Bengaluru
- Review, Author, Execute, perform, summarize, report out verification & validation test activities of components to a full system device: Which includes but not limited to:
- Test Plans, Test Procedures, User and Functional Requirements testing,
- Design Verification,
- Installation/Operational/Performance Qualification Protocols,
- Traceability Matrices and
- Final Reports.
- Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables.
- Clear understanding of the elements of Risk Management, FMEA, critical / Essential parts identification, System reliability, Life / limits testing and related V&V; tasks.
- Participate in the development of Verification & Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry best practices
- Lead the qualification of lab area, productivity improvement efforts, including testing, building fixtures, calibration and data collection.
- Diagnose, isolate and investigate problem reports. Drive product improvements and/or bug fixes.
- Ensure good documentation and Valuable Manufacturing practices are followed in the Verification and Validation Process
- Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives
- Deep knowledge in test automation tools and realizing test automation suite.
- Work closely with the auditees to understand the details and support with all relevant objective evidences
- Adheres to Baxter Quality Management system & supports the quality audits.
- Support on-going regulatory agency inspection readiness through the self-assessment program to include mock inspections and compliance with revised and emerging regulations.
- Pair up with design & development team to start the testing early in the design cycle to ensure the requirements testability, design traceability & test coverage. Identify issues early to fix the same. Refine the test
📌 Sr Eng, Software V&V (Bengaluru)
🏢 Baxter India
📍 Bengaluru