Experience

• 

  Gupta industries

  Apr 2012 - Jun 2012

  Production trainee

  Worked as a production trainee. Responsible for paper wrapping, winding and packaging of transformer wires.

• 

  La-cast metals and components private limited

  Mar 2014 - Jun 2014

  Trainee stores

  Responsible for maintaining stocks of material, issuing materials as per requirement, purchasing the required stocks and maintaining the daily, weekly and monthly inward and outward stocks.

• 

  La-cast metals and components private limited

  Dec 2016 - Jan 2017

  Intern

  Worked in non ferrous foundry and learned basic concepts and practical aspects of gravity die casting, heat treatment, Chemical composition test, alloy formation and worked in machine shop

• 

  Ezenith education

  Dec 2016 - Dec 2016

  Internship

  Automobile Development Internship

• 

  Vijay fire vehicles and pumps limited

  Sept 2017 - Sept 2017

  Intern

  Learned Centrifugal pump assembly, their testing, installation of centrifugal pump, chemical tanks, safety signals on fire brigade and various welding processes like TIG, MIG, electric arc.

• 

  Adler mediequip private limited

  Dec 2017 - Feb 2018

  Carried out Six Sigma project. Implemented DMAIC approach to to reduce rejection problem of Surgical screw. Used process flow chart, fish bone diagram, control chart, pie chart to analyse the scenario and then used FMEA for risk analysis. Used control chart and process monitoring chart to control the process.In this way rejection level dropped down by 70℅. Worked in Production and Quality Department.Learned various instruments handling like Trimos height gauge, roughness tester, passivation tester, profile projector, Rockwell hardness tester.Learned production flow, production planning process, CNC and VMC machines like Haas, Doosan, Robodrill and their programming.

  • Project Intern

    Mar 2017 - Feb 2018

  • Intern

    Dec 2017 - Dec 2017
• 

  Smith & nephew

  Aug 2018 - Aug 2019

  Qara engineer

  Responsibility:1. SPC, Process Capability Analysis2. Internal, Vendor Audit3. Customer Complaint Handling4. Batch Release5. Preparation of Sampling Plan as per ISO 2859 & ISO 3951Learned:Validation, CAPA, Field Action, Engineering and document change control, CMM programming and operating, Electropolishing, Quality control

• 

  Meril

  Sept 2019 - now

  • Deputy Person Responsible for Regulatory Compliance (PRRC)• Conduct Risk Management meeting to carry out activities as defined in ISO 14971.• Preperation of Risk Management Plans and Reports.• Preperation of Usability Engineering Files.• Preparation of technical documentation as per EU MDR.• Identification of required tests and preperation of performance test summary of orthopaedic knee, hip and trauma implants.• To carry out international and domestic supplier audits as per ISO 13485, ISO 9001 or EU MDR requirements.• Participate in internal quality audits.• Member of change committee and CAPA cross functional team and complaint investigation team.• Review of process validation protocols and reports.• To carry out routine maintenance and continuous improvement of Matrix Requirement Software ( software based QMS)• To participate in external product and QMS audits. Show less Responsible for:• Risk Management as per EN ISO 14971 for products such as Knee, Hip, Trauma system, Surgical Sutures, Surgical Staplers, Tissue Adhesive, Bone Wax, Ligating Clips, Etc.• Usability Study as per IEC 62366:2015 of Orthopedic and Endosurgery products.• Technical Documentations as per EU MDR• Internal Audit scheduling and execution.• Review of process validation documents• Member of CAPA cross functional team.• Customer Complaint Handling• Supplier Quality related activities such as supplier audit, Supplier Quality documents review.• Product performance Evaluation of orthopedic implants (Knee, Hip and Trauma system)• Implementation of statistical tools & techniques throughout the Quality Management System.• Coordination with PMS, Clinical and other documentation team as a technical person.• To participate in External Audits & Regulatory inspections etc.• To perform any other task as assigned.• Implementation and maintenance of Software based QMS. Show less

  • Manager - QA/RA

    Apr 2024 - now

  • Assistant Manager - QA/RA

    Apr 2022 - Mar 2024

  • Sr. Executive - QA/RA

    Apr 2021 - Mar 2022

  • Engineer - QA/RA

    Sept 2019 - Mar 2021