CURRICULUM VITAE

KEMPARAJU

S/O Bhattaiah

#***,**** *****, *** *****

Hebbal

Mysore

E-mail id:-acz8di@r.postjobfree.com

Contact no: +91-872*******/889-***-****

OBJECTIVE

To work in a challenging environment, where i can unleash my skills and knowledge with full dedication towards the accomplishment of the organization goals.

EDUCATIONAL QUALIFICATION

Qualification

Institution

Year of Completion

% Marks

SSLC

PRM Composite PU College

T. Narasipura

2007

74

P.U.C

PRM Composite PU College

T. Narasipura

2009

60

ENGINEERING

MECHANICAL Engineering, Government engineering college

Chamarajanagar

2010-2013

65

SKILLS

ISO 13485, ISO 14971, IEC 60601-1, IEC62304, Quality management, QA etc

IEC60601-1-11, IEC60601-1-3, IEC60601-2-49

Witness of Packaging validation testing at CQAE & IEC 60601-1, IEC 60601-2 Testing at TUV

Design Tools: CATIA V5 and Solid works

Verification & Validation and Standard mapping

Preparing medical device Technical file for CE mark submission

WORK EXPERIANCE

Total Year of Experience: 3 Years 6Months

a.Company Name: Magna InfoTech pvt ltd

Client: Wipro technologies, Bangalore

Designation: QARA engineer-PES (Presently working)

b.Company Name: Caliber Assurance Services, Bangalore

Date of joining: 12- Sep- 2013

Designation: Regulatory consultant- ISO 13485 & ISO 14971 and Mechanical R&D

c.Designation: Supplier Quality engineer (1 Year experience)

Client: Skanray technologies, Mysore

Quality inspection of X-ray device parts (Mobile x-ray, C-arm device)

Preparing plan for the execution

Handling CAPA process, Root cause analysis

Supplier Evaluation

d.Neurosurgical Device-Preparing Technical construction file for CE marking of the device (Class IIa) and ISO13485:2012 certifications (QMS & Process establishment)

Preparing Risk management report & FMEA

Exhibiting QA process

Quality management system process

Design Verification & Validation

Application of ISO 10993 & Packaging validation testing

Preparing machine validation reports, Inspection template & reports

e.Patient monitoring Device-Preparing Technical construction file for CE marking of the device (Class IIa device)

f.X-ray Device (C-Arm) -Writing & execution of test cases with respect to requirements (Verification-System integration testing)

g.ENTraview ear screening device-CE marking & Electrical safety testing (IEC60601-1 & IEC60601-1-2)

h.Spirometer-Mechanical R&D and clinical trials (Presently working)

Preparing Risk management report (ISO14971:2012) & FMEA

Preparing PRD, Design document, IFU etc

Mechanical product design (Solidworks)

ACHIVEMENTS

Successful completion of CE & ISO 13485 certification for two Neurosurgical class IIa medical devices.

Submission of Technical construction file for Class I and Class IIa medical devices for CE certification

STRENGTHS

Positive Attitude, Ready to take responsibilities, Proactive, Punctuality, Dedicated towards my job, Confidence, Cool and calm thinking, highly ambitious.

ACADEMIC PROJECT

Title: HOVERCRAFT

Organization: Govt. Engineering College, Chamarajanagar.

Project aim: Designing of “HOVERCRAFT”.

Title: PATH DEFINDER ROBOT (Two days training)

Organization: Ekalavya institution of Engineering, Ummattur.

Project aim: Designing of “PATH DEFINDER ROBOT”.

PERSONAL DETAILS

Father’s Name : Bhattaiah

Date of Birth : 12-02-1991

Marital Status : Single

Sex : Male

Nationality : Indian

Languages Known : Kannada, English & Hindi

Hobbies : Photography, Pc Games, Searching for new technologies etc.

DECLARATION

I hereby declare that the information’s given above is true and correct to the best of my knowledge.

Place: Mysore (Kemparaju)

Date:

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