SETHURAMAN ANDIAPPAN

*** ******** *****, ********, **

Phone: 682-***-****

E-mail: adhxsi@r.postjobfree.com

www.linkedin.com/in/sethuraman-andiappan

EDUCATION

Master of Science

Mechanical Engineering

The University of Texas at Arlington, USA

Jan 2016 - Dec 2017

Bachelor of Engineering

Mechanical Engineering

Anna University, India

Apr 2010 - May 2014

CERTIFICATIONS

CQE (Certified Quality Engineer)

Certificate ID: 104787

ASQ

Oct 2020 - Oct 2023

CSSGB (Six Sigma Green Belt)

Certificate ID: 20309

ASQ

No expiration

PROFESSIONAL EXPERIENCE

B Braun medicals Inc.

California, USA

Quality Engineer (Contractor)

September 2019 – October 2020

Projects: Successfully initiated and closed CAPA associated with FDA site level warning letter for ISO 9001, 21 CFR Part 11, data integrity/retention and regulatory compliance.

Conducted project audits in all areas of business units based on FDA requirements. In results, provided compliance solutions & project management support for remediation efforts.

Determined data related to CPPs, CQAs, cleaning, alarms and line clearance that affects the product quality, patient safety, regulatory compliance and delivered an assessment report for batch review and release.

Executed test method validation and ensured process is fail safe when the parameter exceeds the validated range.

Performed risk analysis (PFMEA) on the potential gaps determined, assessed RPN, performed root cause analysis for business units.

Worked cross functionally with different departments to perform gap analysis and determined current control measure is not capable of addressing the gap. Suggested interim and long-term control measures.

Written test protocols for implementing interim controls, training operators and VOE. Described the assessment methodology, defined methodology for highest risk and most vulnerable data and identified risk mitigation measures for all business units.

Performed verification of effectiveness (VOE) and ensured the successful implementation of immediate measures and effectiveness of training program.

Analyzed data life cycle and mapped data flow for all business units. Mapped data generation, data transfer, data archival and retention.

Jabil

California, USA

Quality Engineer

Jul 2019 – Aug 2019

Experienced on FAIR, BKM checklist and submitted problem reports (PR). Lead the CAPA investigation process for problem resolution and continuous improvement.

Precision Swiss Products

California, USA

Quality Engineer

Jun 2018 – Jun 2019

Experienced in ISO 13485 – QMS and ISO 9001 environment for class II and class III medical device products.

Experienced in preparation of PPAP – Control plans, inspection plans, GR&R, ECNs and FMEA (ISO 14971).

Involved in part qualifications – First article report, in-process inspections. Hands-on experience in Calipers, Micrometer, Optical comparators (Keyence & Mitutoyo).

Assisted in conducting new product optimization tests (DOE) based on CPPs prior to production release.

Reduced tooling cost and downtime over the period by CAD modelling (SOLIDWORS) custom tools to meet drawing requirements.

Performed reliability analysis on tool life & saved $12000 annually by predicting proactive tool change. As a result, reduced unwanted set-up time and scrap rate.

Performed data collection & CAPA implementation for component failure & increased yield by 12%.

Lead incoming inspection via interpreting drawings (GD&T) to redline CTQs and created sampling plans for lot acceptance (ANSI Z1.4-2003) based on critical features determined.

Validated measurement systems & methods using GR&R tests to ensure stability & update calibration reports.

Performed trend analysis for machine availability & downtime based on data collection from ERP system to assist Scheduler.

Monitored and generated periodic reports for six sigma quality metrics (Cp, Cpk, RTY and COPQ)

Lead MRB team, dispositioning the materials, handling warranty issues, worked with vendors on rework.

Pegatron

California, USA

Quality Engineer

Mar 2018 – Jun 2018

Responsible for Outgoing Quality Control & functional testing through AQL sampling to ensure product meet standards.

Vibrant Engineers Pvt. Ltd.

Tamil Nadu, India

Quality Engineer

Jun 2014 – Dec 2015

Monitored field-level performance and reported on the status and potential improvements through research and root cause analysis.

SKILLS

Problem solving

Problem Identification

Lean Manufacturing

Acceptance sampling

Pareto Charting

Continuous Improvement

APQP

Quality Control

Failure Analysis

KAIZEN

Fishbone

8D

MSA

5WHY

SPC

SOFTWARE

MS office

MS Visio

SOLIDWORKS

E2 (ERP system)

PROLINK (Data collection and analysis software)

MINITAB

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