Quality control and Quality Assurance

PAVITHRANAR

NO: B,** Meenakshi illam, **/*, shiyamala street, Email Id: **.*************@*****.***

Neelankarai, Chennai. Pin – 600115 Contact no: +91-979******* PROFESSIONAL

PROFILE

Experienced quality control specialist with a good organizational skill and documentation and control of procedures and processes to comply the requirements of QMS and regulatory.

ISO 13485 2016, ISO 9001 2015

AUTO-CAD

PRO-E

SVN & BUGZILLA

WORK EXPERIENCE Executive-Manufacturing QA (Dec 2014 to till date) Perfint Healthcare Pvt. Ltd - a medical device manufacturing company located in Chennai is a world leader in planning and targeting solutions for image guided interventional procedures

- with an emphasis on oncology and pain care.

MAXIO, ROBIO EX and PIGA CT.

PROJECTS WORKED ON MAXIO

ROBIO EX

PIGA CT

KEY RESPONSIBILITIES Complying to Internal & External Audits

ISO (ISO 9001 & ISO 13485) & CE requirements and complying

Customer complaints handling & closure

Verification and Validation of design changes / developments

Change management as per FDA guidance

Preparation and updating Technical files/documents for CE and client's requirements

Investigating failures through statistical analysis & closure (CAPA)

Managing Device History Record (DHR)

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RESPONSIBILITIES

(CONTINUED….)

Incoming parts inspection of all receiving parts through reading part drawings and specifications and measuring PPAP samples against the part requirements.

Quality documents preparation & review.

Working environment control & monitoring.

Interaction with supplier regarding Non-conformity of parts.

All testing/Measuring Instruments calibration & monitoring.

Corrective action & preventive action (CAPA) review with quality head.

Implementation & monitoring CAPA.

On site inspection/validation at supplier end for part/product quality improvement.

NCMR, NCPR, Deviation handling.

Supporting R&D department.

Responsible for 5S in factory.

Monthly report to Management & Department head.

Communicating design issues to customers through supplier DFM's

Maintaining supplier performance in quarterly basis

Drawing and GD&T knowledge

Final product inspection.

Mechanical Assembly and Integration, orthogonal testing. EDUCATION DIPLOMA – Mechanical Engineering Percentage: 70 Government Polytechnic College, Trichy, (DOTE) 2011 to 2014

SSLC – 10 Standard Percentage: 92

Dalmia Hr. Sec School, Dalmiapuram. (State Board) 2010 to 2011 PROJECT

IMPLANT TRAINING

“Sensor operated pneumatic loading system for trucks” in Diploma TVS Tread, Sundaram Industries Ltd – I got knowledge about manufacturing process. SOFTWARE SKILLS MS-OFFICE

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FIELDS OF INTEREST Manufacturing

QMS

Regulatory

PERSONAL PROFILE Father’s Name : Ravi .A

Date of Birth : 08/11/1996

Nationality : Indian

Marital Status : Single

Languages Known : Tamil & English

STRENGTHS Team worker

Quick learner

Adaptable to requirement

HOBBIES Video Gaming

Drawing

Cooking

DATE :

PLACE : Chennai (AR.PAVITHRAN)

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