• Gender: Male
• Age: 35
• Designation: Senior Engineer (Quality Assurance)
• Highest Education Level: Graduate - Degree
• Notice Period: 30  Days
• Preferred Location: Tamilnadu
• Work Experience: 10.3 Year(s)

Education

B.E.( Mechanical Engineering ) Annapoorana Engineering College, Salem Anna University, Tamilnadu 6.63 CGPA 2014

Skill Sets

Operating system : All Windows versions.
Software : MS Office, AUTOCAD.
Well versed in Internet usage.

Work Experience

Senior Engineer (Quality Assurance)
Sept 2018 to Present
Company Profile : Engaged in the manufacturing of precision injection and blow Molded plastic Medical device components, & Assemblies for healthcare industries. Key products: Parenteral, Diabetes, Ophthalmic, Inhalation delivery devices, Key customer: Cipla, Lupin, GSK, Glenmark, Novartis, Microlabs, Akums, Indoco etc.

Executive - (Medical Device)
July 2016 to Sept 2018.
Company Profile : Premier bio-pharmaceutical company. Key products: Insulin Pen (BASALOG ONE), Insu Pen, Syringes.

Job Profile :
Experienced in handling of QMS on ISO 13485, ISO 15378, 21 CFR 820, US DMF type III & MDD (CE for class 1M) regulations compliance for medical devices.
Experience in new product development activities like preparing Design History Files, Device Master Record and Quality Test Plan of drug delivery medical devices.
Developing testing methods, writing quality testing procedures & QMS SOP’s to ensure compliance of the QMS system.
Having very well knowledge about GD&T & measuring instruments.
Experienced in detail review of Device History Record & review of external documents like instrument calibration reports, Medical Device & medical grade raw material testing reports as per USP, EP & ISO regulation requirements.
Experienced in handling of Deviation, change management, Complaint Management (Root Cause analysis & CAPA), Technical Support to customers & Risk Management as per ISO 14971 (FMEA) for medical device as per regulation guidelines.
Experienced in handling of Process Validation activities of medical device assembly machine & Injection Moulding Machines.
Experienced in reviewing of cleanroom validation (ISO class 8) documents and regular monitoring of clean room environment results as per ISO 14644 requirements.
Experienced in Preparing of Gamma Sterilization Validation protocol & reports for drug delivery medical devices as per ISO 11137.
Strictly adhered Good Documentation Practices (GDP) & current Good Manufacturing Practices (cGMP).
Experienced in conducting and preparing of reports for internal, supplier qualification audit. Preparing of audit compliance report for customer audit & notified body.
Certified internal auditor for ISO 13485, ISO 15378 & ISO 14001.

Quality Assurance Engineer
Oct 2015 to June 2016
Company Name : Nathan & Nathan Consultant Pvt. Ltd.,

Quality Assurance Engineer.
Jul 2014 to Jun 2015
Company Name : GI Auto Pvt. Ltd
Company Profile : They are Manufacturers of high precision turned valves and automobile components.Key Clients :TYCO fire and security, TYCO Pentair, FLOWSERVE, TVS, BMW, BOSCH.

Job Profile :
Preparing & maintaining quality department document like quality plan, quality method etc., also Attended Internal and External Audits.
Experience in measuring various parameters of turning, milling & casting components.
Having detail knowledge in visual inspection standards for casting components & Responsible for daily In-house Rejection & Rework Analysis.
Regular review with supplier /sub – contractors through frequent visits to their work spot and developed them as per our quality requirements.
Followed standard operating procedures, manuals & work instruction for quality operations for the unit.
Reduced rejection level & rework through continuous up-gradation of quality circle to observe better compliance in line with the changing customer requirement.
Knowledge in (GD & T) Geometrical Dimensioning and Tolerance, PPAP documents & 7 QC Tools.
Well Handling of Instruments like Digital & Analog Vernier, Digital & Analog Micrometer, Surfcom Roughness Tester, Profile Projector, Coating Measuring Machine, Torque Wrench, Thread Ring & Plug Gauges, Plain Ring & Plug Gauges, Snap Gauges, Bevel Protector, Bore Gauges, Dial Gauges, Height Gauge, Depth Vernier etc.,
Experience in Internal & External Calibration of Measuring Instruments & Maintaining of Calibration Related documents.

Certificate And Training
Certified Diploma In Industrial Safety Course From Annamalai University.
Certified PRO-E/CREO Designing course from CADD CENTRE, Salem.
Certified In Plant Training At The India Cements Limited, Dalavoi. Ariyalur Dist, Tamilnadu.

Future Goals

To be a part of an organization where I can fully utilize my skills and make a significant contribution to the success of the employer and at the same time my individual growth.