Career Objective:

Seeking opportunity to work as the quality assurance/system

engineer with a global leader in engineering and manufacturing to establish and develop the process improvements throughout the departments of theorganization.

S.Nandha Gopal.DME,B.E

Assistant Management

Representative-Q/A -Quality

Management system

Experience: +3Years

Phone No: +91-852*******

Email:

adonbt@r.postjobfree.com

PermanentAddress:

2/52-Aranmanai Street,

Zameen Muthur,

Pallakad Road,

Pollachi-642005

Personal Data:

Father’sName: N.Sivalingam

Date ofBirth : 18.02.1997

Nationality : Indian

MaritalStatus: Unmarried

Areas ofinterest:

Foundry and fettling Process

Qualityinspection

NDT Inspection

Quality Audit

Process Control

System Handling:

• MSoffice(Excel-PowerPoint,

word)

• AutoCad

• Solidworks

Languags Known:

English & Tamil

Passport Details:

PassportNumber: N9267956

ValidUpto : 15/08/2026

Professional Experience

(Roles& Responsibilities)

Position Title ;Assistant Management Representative Duration :October 2020-Present

Company Name: Gesco Health Care Pvt limited

Chennai,Tamilnadu

Preparing Medical device file and Standard operating procedures as per the standards

Conducting periodic internal audit for the Production, Drug,Design

Perform daily process verification audit in all departments for elimination of system deviations in regular activities.

Review actions taken and effectiveness verification for non- conformity audit during the previous audit.

Plan and take action for the follow up audits for the improvements in respect department process.

Controlling and maintain the Quality management systems records as per the ISO13485 and 9001.

As per the record room controlling .Work orders follow-up and batch records maintaining.

Planning and arranging the calibrations for the equipments and maintaining the documents.

Review and preparing the documents for the MDR Compliance for CE markings .

Ensure the products are compliance with the FDA quality system regulations.

Conducting Non conformity review meeting weekly to ensuring the performance .

Conducting safety auditing and work place audit

1

Position Title ;Assistant Management Representative Duration :November 2019- October 2020

Company Name: United Group of Companies Pvt limited Coimbatore,Tamilnadu.

Daily sand process control and production quality control as per the standards and integrated management systemprocedures

Assist in development of quality process,records management and documents control,controls of electronics data,quality site management observing departments and systematiccontrolling

Ex cute the development,implementation and continued improvement of quality management system through out theoperation.

Work with engineers and managers to create and implement the QA procedures and process.Determine the root causes and corrective action for respect process andprocedure

Actively monitoring the effectiveness of the process and quality of project work with management,and propose and execute the quality and processimprovements

Working on the PPAP, FMEA,APQP and control plans. Position Title : AssistantEngineer.

Duration : June 2016-July 2017

Company Name: Magna Electo castingss Pvt limited

Coimbatore,Tamilnadu.

Conduct internal quality audits to ISO requirements

Plan the Work place and safety auditing in operationareas

Maintain equipment calibration schedule andrecords

Knowledge of manufacturing processes and relevant statistical techniques

TPM implementation in respectivedepartment

5’SImplementation

Processaudit

ProductAudit

Manage raw materials and man power for daily productionactivity

Prepare work schedule and monitor the productionactivities

Analysis gap for the plan and actual of productionplan.

Preparing and submitting the weekly and monthly production status for thehead

Contract billing preparation and submittingprocess Technical Proficiency:

PositionTitle :Diploma EngineeringTrainee

Duration :June 2015-May 2016

Over all Foundry process and Fettling process and Heat Treatment learning.

Observing Process each departments and systematiccontrolling.

Maintain DAILY WORKMANAGEMENT.

IMS Procedure Preparing andImplementation.

Prepared Skill Matrix for process wise and Productwise.

Determine the Root causes and Corrective action for respect process andproducts.

Process and products Timingstudied.

Collaborating with all levels of Production, NPD, and SupplyChain Bachalore of Engineeing

P.A.College of Engineering and Technology.Pollachi, Anna University,Chennai-7.8% CGPA

2017-2020

Diploma in Mechanical Engineering.

P.A.Polytechnic College, Director of technicaleducation-94% 2012-2015.

Secondary School Leaving Certified.

Tmt.Rukkmaniammal Higher Secondary School-81%

2011-2012.

Education:

Education:

PREPARING INTERGRATED MANAGEMENT SYSTEM

DOCUMENTIONS

ISO 9001 :2015 QUALITY MANAGEMENT SYSTEM

ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEM

ISO 13485:2016 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM

MEDICAL DEVICE FILE PREPARATION

CE MARKING

FDA DOCUMENTATION

NPD PROJECTS CUSTOMERS DOCUMENTATION .

BATCH RECORDS AND ERP CORDINATION

References:

LinkedIn:nandha-gopal-564825167

Mr.Karthick-Chief Executive officer-

Career Tree HR solution.

Chennai,Bangalore,.

Mr.Yoga Ganapathy-lead ( HR)

SUNDARAM MOTORS

MERCEDES BENZ, Coimbatore.

Contact this candidate