Sai Prateek Kollipara

Senior Quality Engineer @Abbott

Owned continuous improvement initiatives as appropriate for the calibration & artwork proofing process. • Assists in the development, approval, and change control of design history documentation (e.g. Design Inputs, Design Outputs, Trace Matrix, Design Verification/Validation, Change Impact Assessments, Quality Plans, Work Instructions, Protocols, Reports, FMEAs, etc.) • Monitors and maintain DHF requirements in accordance with project timeline and design control requirements. • Coordinates with Operations and Engineering to implement design control deliverables. • Collect and analyze quality information/data from various quality systems and develop reports, make data driven recommendation/decisions, take appropriate action based on the trends, communicate/report activities and status as needed for senior management review. • Conduct or assist in systems/process/product failure mode and effects analysis and initiation of corrective and/or preventative action as it applies design control activities. • Responsible for review and approval of clinal study protocols and reports.