Meena Chettiar

Medical Device

Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A.SC in Chemical Engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Ms. Chettiar recently completed graduate certification at St. Cloud State University in Applied Clinical Research Program focusing on medical devices. Meena is currently working as a Quality and Regulatory Manager at ProMed Pharma, Medical and combination device manufacturer. Meena has worked as a Senior Supplier Quality Engineer for Covidien with drug coated balloons and guide wires, for Baxter Bio Surgery, as a Senior Quality Manager at Teva Pharmaceuticals for over 10 years and as QC lab supervisor at Land O' Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years. Meena has played a key role in quality system implementations in the food, pharmaceutical, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US and abroad. Meena is the Vice chair of member development for MNASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence). She has served as an instructor for these ASQ certification classes since 2006. She is a certified instructor for ASQ learning institute for CBA and an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota. Meena is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana, used for certification of medical device professionals on the compliance standard requirements. Meena is now working on the Supplier Quality Certification Handbook team.

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This presentation will cover everything you ever wanted to know about the International Medical Device Standard ISO 13485:2016 Released on 01 March 2016 so you can start the gap assessment and make your quality system compliant to the new standard. P ...

Understanding the key regulations and standard requirements to set up a Quality Management System for FDA Regulated Pharmaceutical and Medical Device Manufacturers and Suppliers to the industry is an ever ...