Rajesh Surve

About Rajesh Surve

Mechanical Engineer having 14 years of Experience in the Manufacturing of all the Department speciallyin Quality and Regulatory Affairs. Medical Device professional having experience in 4 Medical device industries as well as Fluoropolymers, Elastomers and Automobile industry. Quality Management system implementer and Internal Auditor for ISO 13485:2016, ISO 9001:2015, EMS ISO 14001:2015 & ISO OHSMS: 45001:2018. Preparation & Revision of Quality Manual, SOP, WIs, QP & forms following Good Documentation Practices. Conducting Internal Quality Audit and Management Reviews as per laid down procedure Facing External QMS Audit like Indian ISO surveillance audit from DNV, SGS,TUV India,Zenith Bodies and updatecompliance in each audit. SAP S4 HANA Implementation for QM, S&D, PM, MM Modules up to the end user. SIX Sigma Project Co-Coordinator and Part of Cross Functional Team. Experience in Developing and determining all standards to set Quality assurance plan, perform inspection and Tests on all Procedures as per the product and customer requirements. Supervise effective implementation of all Test and Inspection schedule and Ensure adherence to all procedures and coordinate with various teams to perform Quality audits on processes. Analyze all products and Non-conformance processes and evaluate all Documents to ensure maintenance of optimal quality and prepare monthly reports to evaluate performance. Monitor an efficient system and record for all project activities and analyze all processes to ensure all work according to quality requirements.Regulatory1.Manufacturing license 2.Import licence 3.FSSAI4.Wholesale License and other Product related license approval4.Fee sale certificate 5.Market standing certificate 6.Test licence of product from NSWS7.Patent Related Activities 8.Trademark9.Drafted a detailed Environmental, Social, and Governance (ESG) report, highlighting key strategic initiatives and sustainability metrics, like strategy development and stakeholder engagement, undertaken by the organization.

Experience

1. Plant Engineer and Iso Co-ordinator

   DuFlon Industries Pvt. Ltd.

   Nov 2018 — Present · Mumbai, IN

   About Company:DuFlon is a leading, world class manufacturer of high-performance Fluoropolymers, Elastomers and Machined Castings. DuFlon serves more than 100 customers spread across 40+ countries and is well integrated into the supply chain of Global P&V Industry. It is also emerging as a leading player in offering Corrosion & Purity Solutions for Global Chemical and Process Industries.Roles and Responsibilities: Production- Forecasting, Scheduling, execution and updating Order Progress Monitoring reports. Customer Visits- Manage Customer Visit. Development- Design and Development of rubber compounds and Molds as per the Customer requirements in molded, lined and extruded products. Purchase- External Service provider identification, Selection, Validation through Supplier Quality Rating. Quality Control- Inspection and setting up parameters. QA- Initiating Internal Audit process and documentation up to NC closures with MRM Minutes. Maintenance- Preventive Maintenance to Breakdown History. System - Implementation of SAP S4 HANA in Plant. Reducing the quality cost with the help of analysis of non-conformances on periodic basis & Coordinating with the development department to improve quality, minimize rejections by following suitable actions (both corrective and preventive). Training and upgradation of Skills of Subordinates, Group Leaders and workmen. Ensure that all the machine in the department run without breakdown and attend to problems. Responsible to maintain the production records such as production report, job card, raw material consumption record, process parameter register etcAchievements-Implemented QMS as per ISO 9001:2015 in DuFlon and got certificate from TUV India.Reduced PTFE liners crack rejection by 50% through six sigma Project

Education

• Government Polytechnic, Ratnagiri

  Diploma, Mechanical Engineering - MSBTE

  2007 — 2010

• ADARSHA HIGH-SCHOOL KURTDADE- RATNAGIRI

  SSC, General Studies

  2005 — 2007

• Institution of Engineers of India (IEI), Kolkata

  A.M.I.E.-MECHANICAL, Mechanical Engineering

Skills

• Kaizen
• Ppap
• Continuous Improvement
• Management
• Project Engineering
• Capa
• Root Cause Analysis
• Quality Management
• Quality Assurance
• Iso
• Business Process Improvement
• Quality Control
• 5s
• Tpm
• Manufacturing
• Process Engineering
• Ce Marking
• Business Development
• Inspection
• Automotive
• Bill of Materials
• Process Improvement
• Poka Yoke
• Regulatory Affairs
• Pdca
• Team Management
• Engineering
• Six Sigma
• Ppe
• Employee Training