
Swathi Nirale
Quality Inspector

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About me
Medical Devices Manufacturer
Education

JNGP
2002 - 2005Diploma in chemical engg.. Chemical Engineering A+
Jadavpur University
2007 - 2012Associate member of Indian Institute of Chemical Engineers Chemical Engineering
Experience

HARVIN SCIENTIFIC OPTICS PRIVATE LIMITED
Dec 2006 - Sept 2007Quality InspectorInspecting 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 - nowSr Manager - Stent Production, Planning & Control
Apr 2018 - Dec 2022Manager-Stent Processing & Stent Quality Control
Apr 2015 - Apr 2018Deputy Manager- Stent Processing & Stent Quality Control
Apr 2013 - Apr 2015Assistant manager
Apr 2011 - Apr 2013Executive- Stents Department
Nov 2007 - Apr 2011
Licenses & Certifications

Trained Internal Auditor in EN ISO 13485 2012
DNV GL - Business Assurance NL | Certificering & TrainingFeb 2015
Lean Six Sigma Green Belt
TÜV SÜDNov 2022
Languages
- hiHindi
- teTelugu
- kaKannada
- enEnglish
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