Rajeev Pratap Singh

-Review of various validation documentation including IQ, OQ, PQ, Traceability Matrices, FMEA. -Performed process capability studies with Ppk & Cpk indexes to analyze processes using statistical software. -Validated test methods and analyzed the data using Gage R&R and Anova studies -Preparation/reviewing of First Article Inspection(FAI) plan.. -Risk analysis and assessment/mitigation carried out for Medical devices as per ISO 14971. -Facilitated PDCA process improvements, decreasing overall errors by 15%.

-Performed Reverse engineering of orthopaedic devices. -Performed Cost optimization without affecting functionality and quality. -Prepared test plan and test report of those devices. -Performed verification and validation testing of engineering models to support adequacy and reformulated models -Worked on Product such as Night Splint and Shoe-lift, analyzed risk that can occur and it's mitigation.

-Confirmed whether all the Raw material suppliers complies to FDA regulation. If not, suppliers are asked to provide documents like ISO standards and Supplier quality agreement etc. -Created plans and communicated deadlines to ensure projects were completed on time.

Score overall CGPA 9.33

Passed high school degree with 89%.