
VIVEK RANGAN C
Graduate Apprentice

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About me
QA Specialist | Regulatory Affairs |Project Management | Internal Auditor - ISO 13485:2016 | MD Labeling | LSSGB
Education

Devi Matric Hr Sec School
2008 - 2010HSC Maths - CS A (90%)
P.S.N.A. College of Engineering and Technology, Dindigul
2010 - 2014Bachelor of Engineering - BE Mechanical EngineeringSuccessfully became a Mechanical Engineer with first class marks (80.5%)

PSNA College of Engineering and Technology
2010 - 2014Bachelor's degree Mechanical Engineering
Experience

Bharat Electronics Limited
Dec 2014 - Dec 2015Graduate ApprenticeI have been posted at Calibration laboratory of Central QA division. My profile is to calibrate all Mechanical (Dimensional) instruments, surface plates and Maintenance Check for lathe, milling and jig-boring machines at various SBUs of BEL (Bg-Cx).In addition to the above, I have also involved in creating/updating the calibration procedure for new gauges.

Videocon Industries Ltd
Mar 2016 - Feb 2018Quality EngineerAs a Quality Engineer I make sure the Quality of Air-conditioners produced by conducting various tests such as Performance Testing, Early Life Testing, Outgoing Quality Assurance Testing, Pre-Despatch Inspection and Smog Testing. I also take care of Process Quality by patrolling the line from initial to final stage.

HCL Technologies
Feb 2018 - Jul 2019Member Technical Staff (Regulatory Affairs)Labelling Engineer | Gap assessment of Labels and IFUs with respect to EUMDR | HCL certified Process Quality Analyst (PQA) | Verifying the correctness of the process followed | Defect Prevention Analyst (DPA) | Root cause analysis of the occurred defects and providing corrective and preventive action to prevent them from recurring | Valur Stream Mapping (VSM) - Automation of labelling gap assessment

Tata Elxsi
Jul 2019 - May 2022Senior Engineer (Quality & Regulations)Gap Assessment of existing tech files with respect to EUMDR. Preparing RA files such as GSPRC, TDS, DoC and final review/approval of all technical documents (such as Product Description, Product Risk Assessment, Biocompatibility report, GSPR checklist) associated with MDR submission. Analyzing the defects for its root cause and providing corrective and preventive action for the same. Analyzing the process and VSM the same. Understanding client expectations on delivery performance and developing an account related plan aligned with account strategy. Show less

Stryker
May 2022 - nowSenior Specialist - Labeling and Technical PublicationReview & approval co-ordination of non-labeling jobs. Contribute to the weekly released report & maintenance of artwork archives.Publication and/or uploading of approved documents on global portals.Translation coordination of technical documentations. Language Independent document formatting. Process and implement IFU/IFP related change requests, including management of approval processes and implementation.Assist as required with Production IFU/IFP issues and problems.Participate in managing the IFU/ IFP system, including review of requirements and existing IFPs/IFPs. Performing change Management activities for ProceduresAssist in corporate oversight of labeling standards, requirements, data, technical solutions, business process, infrastructure, licenses, etc.Initiate and maintain effective collaboration between the Technical Publications team and engineering groups. Show less
Licenses & Certifications

Internal Auditor ISO 13485:2016
SGSJul 2020- View certificate

Project Canvas: A Simple Framework to Learn Project Management Fundamentals
LinkedInApr 2022 - View certificate

Prioritizing Your Tasks
LinkedInMar 2024 
Business English Certificate
University of Cambridge
LSSGB
Asian Institute of Quality Management
Honors & Awards
- Awarded to VIVEK RANGAN CBravo Award Tata Elxsi Nov 2021
- Awarded to VIVEK RANGAN CBRAVO Award TATA ELXSI Jan 2021 I have been awarded BRAVO for submitting quality deliverables within planned deadline and for providing KT for new joiners and guiding them in ramping up with project activities in short span of time.
- Awarded to VIVEK RANGAN CBravo Award Tata Elxsi May 2020 I have been awarded BRAVO by TATA ELXSI for reviewing the tech. files (for MDR submission) with reference to applicable standards and providing valuable inputs to increase the quality of the deliverables without impacting the planned date for submitting the same.
Volunteer Experience
Joint Secretary
Issued by Rotaract Club of PSNACET on Jun 2011
Associated with VIVEK RANGAN C
Languages
- enEnglish
- taTamil
- kaKannada
- teTelugu
- hiHindi
- geGerman
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