Swathi Nirale

Swathi Nirale

Quality Inspector

Followers of Swathi Nirale406 followers
location of Swathi NiraleHyderabad, Telangana, India

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  • Timeline

  • About me

    Medical Devices Manufacturer

  • Education

    • JNGP

      2002 - 2005
      Diploma in chemical engg.. Chemical Engineering A+
    • Jadavpur University

      2007 - 2012
      Associate member of Indian Institute of Chemical Engineers Chemical Engineering
  • Experience

    • HARVIN SCIENTIFIC OPTICS PRIVATE LIMITED

      Dec 2006 - Sept 2007
      Quality Inspector

      Inspecting the processed Concave & Convex Lenses Used to Manufacture RifleTelescope.

    • Relisys Medical Devices Limited

      Nov 2007 - now

      • Plan work flow and schedules for production department.• Evaluate current production status and ensure timely deliveries.• Handling all the OEM Production of bare metallic stents.• Working on Continues yield Improvements, Cost Reduction.• Develop New Technology in cardiac stents manufacturing. Ensure that finished products meet quality standards and Customer specifications.• Determine equipment, materials and manpower required to complete Production & QC activities.• Weekly Rejections reviews to improve the Yield.• Handling Internal Complaints of products.• Working on CAPA by root cause & 5 why analysis and Corrective actions of the same.• Developed the Process of manufacturing the stents with sand blasted/Rough Surface. • Managing Shift Schedules.• Worked on Process Improvements and Process cycle time reductions.• Worked on equipment qualifications and Process Validations. • Follow-Up on the Stent Production & QC Activities.• Maintaining Batch records in accordance with medical devices standards. • Training Manpower on Individual processes in Stent Processing & QC. Worked on developing all the Critical process in Stents Manufacturing (Co-Cr & S.S): 1. De-scaling2. Heat Treatment3. Electro polishing.Preparation, validation & Usage of Different types of Electrolyte.4. Passivation of different metals.5. Surface and Dimensional Inspection Process of Pre-Finished & Finished Stents.

      • Assistant General Manager

        Apr 2022 - now
      • Sr Manager - Stent Production, Planning & Control

        Apr 2018 - Dec 2022
      • Manager-Stent Processing & Stent Quality Control

        Apr 2015 - Apr 2018
      • Deputy Manager- Stent Processing & Stent Quality Control

        Apr 2013 - Apr 2015
      • Assistant manager

        Apr 2011 - Apr 2013
      • Executive- Stents Department

        Nov 2007 - Apr 2011
  • Licenses & Certifications

    • Trained Internal Auditor in EN ISO 13485 2012

      DNV GL - Business Assurance NL | Certificering & Training
      Feb 2015
    • Lean Six Sigma Green Belt

      TÜV SÜD
      Nov 2022