23 Aug
|
Baxter India
|
Bengaluru
23 Aug
Baxter India
Bengaluru
What you'll be doing
- 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.
- 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 valuable documentation practices are followed in the SW Verification and Validation Process
- Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives
- Participate in V&V; development process improvement and test automation.
- Maintains awareness of current regulatory trends and their impact on the Verification and validation status of equipment and processes.
- Support the SMEs on Regulatory responses and Audits, as needed.
- 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 them. Refine the test plans and procedures through pre-verifications / Dry runs.
- Interacts with design team to resolve tests-related technical issues.
- Presents the findings / objective evidence and able to present with rationale with applicability / exclusions
- Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as need
📌 Engineer II, Software V&V (Bengaluru)
🏢 Baxter India
📍 Bengaluru