Overview
• 15+ years in Quality management implementation for automotive manufacturing industry, medical device industry, also worked as production manager and Design Engineer.
• Supplier Quality improvement through implementation of SPC and improvement plan
• Set Supplier categorization based on usage and processing of Implant and Surgical instrument. Implementation of Supplier assessment program and derive supplier rating based on Quality delivery and time.
• Gap analysis of Essential l requirement checklist for CE certification as per applicable ISO standards requirement for Class II and III device
• Design transfer for orthopedic Implant and surgical instrument, coordinating for design validation and prototyping.
• Monitoring and leading US FDA compliance for New product development at Syntel
• Implementation of Statistical Process Capability and Gauge R & R in Minitab at Biorad Medisys
• Perform risk analysis by using DFMEA at Syntel and Biorad Medisys
• I have experience in data Entry in Excel sheet from PDF
• Further Analysis in Minitab or in Excel
• Data entry of Medical Device Study data as inspection report, Analysis Report
Educational Details
DBM (Diploma in Business Management) Year 2000
Vasantdada Patil Institute of Management, Shivaji University
DME (Diploma in Mechanical Engineering) Year 1996
Government Polytechnic Miraj, Maharashtra Board of Technical Education