• Gender: Male
• Age: 38
• Designation: Quality Engineer
• Highest Education Level: Diploma
• Preferred Country: India
• Preferred Location: Tamil Nadu
• Work Experience: 15.3 Year(s)

Education

Diploma in Mechanical Engineering. 12+ Years of work experience in QA&QC.

Skill Sets

Certified internal auditor & Certified by SGS Academy, Bangalore.
Attended External Training Metrology (IMTMA)
Attended External Training First Aid, 5s & Kaizen (WACIA)
Attended in-House Training Program ISO 13485:2012 & ISO 9001:2008
Conducting to QI in-House Training Program Practice (GDP&CGMP).

Work Experience

Quality Engineer
From -Apr 2014 to till date
Company profile - manufacturing of single-use devices for the health care

Quality Engineer
From - Sep 2011 to April 2014
Company profile - Packaging and Device partner to leading global healthcare

Operating Engineer
Mar 2011 to Sep 2011
M/s. TENNACO PVT.LTD,

Trainee Quality
Mar 2010 to Mar 2011
M/s. KARMOBILES LTD

Job profiel -
Preparation & submission of validation reports. SCAR & Internal NC CAPA follow-up.
Preparation of SOPs, Validation Protocol, QPs, WIs, Control Plans.
Molding and assembly DHR & DMR reviewing, handling of metrology inspection activities.
Handling of Product / Process validation activities (IQ, OQ & PQ).
Conducting of MSA study (Gauge R&R) & Minitab analysis.
Handling of cleanroom validation activities quarterly for microbial test of Class 7 & 8 Cleanrooms.
Inspection reports & FAIR reviewing.
Handling of customer complaint.
Handling of internal & external NCMR, 8D, and Deviation follow-ups.
Maintaining & Planning the Instruments calibration on monthly basis.
Preparing Certificate of analysis, Certificate of compliance.
Introducing new ideas in to action to increase the quality level and productivity.
Conducting internal training to quality people to increase the product quality.
Manpower utilization quality people & overall Production area such as Machine operation,
Assembling, Incoming, Final inspection etc.
Handled almost plastic components like Rubber, PP, HDPE, LDPE, LLDPE, Surlyn, Pc Clear, Du-pont, ABS Lustran & Tool room support for steel inspection.
Good communication skills, analytical skills and ability to work under pressure.
Instruments Knowledge:
VMM (Micro VU), VMS (Vision Measurement System), CMM Brown & Sharp gage 2000(Co-Ordinate Measuring Machine), Particle Count Monitor (Fluke & Airy), Profile projector, Tool micron microscope, Hardness tester, Roughness tester, Tensile tester, Vacuum leak tester, Torque tester, MFI Tester, Digital Caliper & Digital Micrometer, Digital height gauge, Peel & Creep tester, depth gauge, thread pitch gauge & Screw gauge etc.
Achievements:
I got an exceeding expectation award for accurate & precise metrology inspection
From SMC Ltd year 2015-16.
I got second exceeding expectation award for Extensive support for validation.
From SMC Ltd year 2018-19.
Improved Team work & Improved quality Documents.
Implementation of 5S, 8 Disciplines & KAIZEN