Ashwin Barathi Elango
About Ashwin Barathi Elango
Ashwin Barathi Elango is a Senior Quality Engineer at Boston Scientific with extensive experience in regulatory compliance, validation, and quality assurance across various industries.
Current Company
Ashwin Barathi Elango is currently employed at Boston Scientific as a Senior Quality Engineer. He has been with the company since 2019. Boston Scientific is located in the Toronto, Canada Area, where Ashwin is involved in ensuring product quality and regulatory compliance.
Professional Experience
Ashwin Barathi Elango has accumulated a diverse range of experiences in the field of Quality Engineering. His career includes roles such as Quality Assurance Engineer at CardioMed Supplies Inc. in Lindsay in 2019, Lead Engineer at HCL Technologies in Chennai from 2017 to 2018, Quality Engineer at Terumo Cardiovascular Group in Ann Arbor, Michigan from 2015 to 2016, Quality Engineer at Zimmer Biomet in Warsaw, Indiana from 2014 to 2015, and Junior Project Engineer Trainee at Swagat Precision Products (P) Ltd in Coimbatore, India from 2011 to 2012.
Educational Background
Ashwin Barathi Elango has a comprehensive educational background, having completed his Master's degree in Industrial Engineering at the New Jersey Institute of Technology from 2012 to 2013. He also holds a Bachelor's degree in Mechanical Engineering from Amrita Vishwa Vidyapeetham, Coimbatore, completed between 2007 and 2011.
Expertise in Regulatory Compliance
Ashwin has demonstrated expertise in regulatory compliance, particularly with 21 CFR Part 820 – QSR and SOR/98-282 standards. His work typically involves gap analysis and the creation of remediation plans to ensure adherence to Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) environments.
Skills in Validation and Analysis Techniques
Ashwin Barathi Elango is proficient in various validation and analysis techniques, including Design History File (DHF), Design of Experiments (DOE), Statistical Process Control (SPC), Fault Tree Analysis (FTA), and Failure Mode and Effects Analysis (FMEA). He develops and implements validation plans for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Experience in Test Method Validation
Ashwin has extensive experience in conducting Gage Repeatability and Reproducibility (Gage R&R) studies and Test Method Validation (TMV) for both attribute and variable data. He also excels in creating and managing engineering specifications, work instructions, and test procedures to ensure product quality and compliance.