24 Aug
|
Baxter India
|
Bengaluru
24 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.
Explicit 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 positive 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