Anjali Pillai
Bengaluru
Summary
Dedicated and detail-oriented Customer Quality Specialist with over 8 years of experience in the medical devices industry, specializing in Post-Market Surveillance (PMS), regulatory reporting, and customer complaint management. Proven expertise in U.S. FDA regulations (21 CFR Part 803, 820.198), ISO standards (ISO 13485, ISO 14971), and cross-functional collaboration. Adept at leading investigations, driving CAPAs, and ensuring continuous improvement in product quality and compliance.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Customer Quality Specialist
TATA Consultancy Services Ltd.
06.2016 - Current
- Spearheaded complaint management lifecycle of sterilizers, disinfectants, and related consumables for ASP.
- Acted as Technical Lead for a team of 10 investigators; ensured adherence to internal SOPs and global regulatory requirements.
- Oversaw complaint intake processes—categorized user data per FDA and internal work instructions, initiated product complaints in the database, and assigned failure mode categories.
- Conducted triage and reportability determination per 21 CFR 803; submitted adverse event reports to authorities.
- Coordinated with Field Service Engineers globally to collect troubleshooting information and complete database documentation.
- Managed product return logistics, including RMAs and return shipping for in-house evaluations.
- Authored investigation reports summarizing nature of complaint, DHR review, trending data, root cause, and risk assessment.
- Led CAPA processes, including product recalls, lot restrictions, and process improvements.
- Managed customer service workflows: replacements, credit, returns, and complaint mailbox.
Education
Master of Engineering - Communication Systems
PSG College of Technology
Coimbatore05-2016
Bachelors of Technology - Electronics and Communication Engineering
MES College of Engineering
Kuttippuram05-2013
Skills
- Quality & Regulatory: Complaint Management (21 CFR 820198), Medical Device Reporting (21 CFR 803), Risk Management, Post-Market Surveillance
- Standards & Systems: ISO 13485, ISO 14971, QMS
- Complaint lab product processing
- Good Documentation Practices
Additional Information
- Hands-on with complaint handling tools: Oracle Siebel, Salesforce CRM, Med-Vantage, One ASP
- Regular interaction with cross-functional teams including Regulatory Affairs, Field Service, and Client QA/RA teams globally
- Strong documentation and analytical skills; proficient in MS Excel, Word, PowerPoint
Accomplishments
- Recognized with On the Spot Award, Special Initiative Award, Star of the month for outstanding contribution.
- Reduced complaint closure time by 20% through strategic process enhancements and team collaboration.
Certification
Introduction to Quality System Regulation TATA Consultancy Services Ltd. December 2018
FDA Regulation 21 CFR Part 820 TATA Consultancy Services Ltd. December 2017
Software development standard for medical devices TATA Consultancy Services Ltd. December 2016
Basics of Medical Devices TATA Consultancy Services Ltd. December 2016
Timeline
Customer Quality Specialist
TATA Consultancy Services Ltd.
06.2016 - Current
Master of Engineering - Communication Systems
PSG College of Technology
Bachelors of Technology - Electronics and Communication Engineering
MES College of Engineering
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