Manikandan Perumal
IRCA and CQI Certified Lead Auditor for ISO 13485 | Medical Device Inspector | QSR, MDR, DHR, CAPA & Vigilance Audit Experience | 13 Yrs in Quality Assurance l IGMPI
- Role
- Quality Inspector at Medline
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Manikandan Perumal
A highly skilled and certified ISO 13485:2016 Lead Auditor (IRCA Certified) with over 13 years of experience in product quality and 8.5 years of experience in the medical device manufacturing industry. Expertise in QMS compliance (QSR, GMP, ISO 13485), internal and external auditing, medical devices inspections, CAPA handling, and supplier evaluations. Strong knowledge of international regulatory standards, including MDR, FDA 21 CFR Part 820, and ISO standards. Proven ability to support and lead quality systems audits and drive continuous improvement in compliance.
Experience
Quality Inspector
Jan 2017 — Present · IN
Support and execute QSR audits (as per ISO 13485 & 21CFR820) in compliance with standards and regulations with approved vendors Implementation of QMS activities with suppliers Complete product inspections per approved inspection criteria and specifications as per SOPs and QPs Develop, Implement and maintain a Quality assurance and management system in full Alignment with ISO 13485, ISO 9001, and 21 CFR 820 with new suppliersApplying the QMS tool (ETQ reliance) for creating and monitoring the Non-conformity and inspection process Conducting Supplier’s Pre-Assessment Audits (GMP audit & Environmental audit, P & PC) Conducting PP meetings with vendors to foresee the technical issues and alert highlighting the factory Knowledge of the application of Regulatory requirements including ISO 13485, FDA, and International
Education
Institute of Good Manufacturing Practices India (IGMPI)
Post Graduate Diploma in, Regulatory Affairs (medical device as major)
Pavendar Bharathidasan College of Engineering and Technology
Bachelor of Technology (B.Tech.), Textile Sciences and Engineering
2011 — 2014
Sri Ragavendra Polytechnic College
Diploma, Textile Processing
2007 — 2009
Skills
- Powerpoint
- Microsoft Excel
- Microsoft Office
- Microsoft Word
- English
- Research
- Merchandising
- Manufacturing
- Textile Industry
- Quality Control
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