ANUP KRISHNAN C
THIRUVANANTHAPURAM,KERALA
Summary
Quality Assurance Engineer with extensive expertise in post-market surveillance and complaint handling within the medical device sector. Skilled in global regulatory compliance, including FDA 21 CFR Part 820, ISO 13485, and EU MDR. Proven ability in root cause analysis and trend monitoring, enhancing audit support and regulatory readiness.
Overview
9
9
years of professional experience
3
3
Certifications
Work History
Quality Assurance Engineer
Terumo Blood & Cell Technologies
Thiruvananthapuram, kerala
10.2018 - 06.2025
- Investigate, analyze and process product complaints to determine root causes and assess impact on product quality and patient safety.
- Maintain and update complaint documentation within the quality management system (QMS).
- Prepare detailed investigation reports, complaint metrics and trend analysis for internal stakeholders and audits.
- Support internal and external audits by providing accurate complaint data and ensure regulatory compliance (ISO 13485, FDA 21 CFR Part 820, EU MDR).
- Collaborated with cross-functional teams to enhance complaint categorization, aligning issues with product design to improve investigation accuracy.
- Responsible for statistical analysis of post market surveillance data, Generation of monthly trend reports and escalation of monthly trends to NC/CAPA/SCAR when statistical thresholds are reached.
- Responsible for the holistic processing of medical device performance issues (including investigation, documentation, review, and closure). Ensuring adverse events are filed with the relevant reporting bodies within the respective timeframes.
QA/QC Engineer
Vikram Sarabhai Space Centre Trivandrum
Thiruvananthapuram, Kerala
03.2016 - 09.2018
- Study of Production & Planning Activities
- Feasibility study of jobs & study of drawings.
- Material planning, Process planning & Production planning.
- Preparation of Route Cards & Process drawing.
- Dealing with projects, providing inputs for manufacturing feasibility for realisation of components.
- Co-ordination of different manufacturing section & inspection.
- Online Quality Surveillance for Stage Auxiliary systems viz, PSOM XL Separation System, PS2&PS3 Separation Systems, Retro-1,Retro-2 & Ullage Rocket Jettisoning System, Heatshield Separation Systems, Payload Cooling Umbilical (PCU) and Satellite Separation System
- Preparation of Flight Readiness Report (FRR), Online QC Reports and Stage Clearance reports for different systems.
- Qualifying of flight fasteners and issuing of tags
- Non-Destructive Testing of Flight components like Bands, Connecting Bolts, Rollers, Shearpins, Fixtures etc.
Education
Masters in Engineering - Manufacturing Engineering
CSI Institute of Technology
Tamilnadu08-2016
Bachelors in Technology - Mechanical Engineering
Sarabhai Insitute of Science And Technology
Thiruvananthapuram07-2012
Skills
- Root cause analysis
- Quality management system
- Regulatory compliance
- Statistical analysis
- Complaint documentation
- Product lifecycle management
- Communication
- Team Work
- Critical Thinking
- Leadership
- Adaptability
- Project Management
Languages
English
Professional
Malayalam
Professional
Hindi
Professional
Tamil
Professional
Certification
ISO 13485 Lead Auditor Certificate by The Knowledge Academy
Timeline
Quality Assurance Engineer
Terumo Blood & Cell Technologies
10.2018 - 06.2025
QA/QC Engineer
Vikram Sarabhai Space Centre Trivandrum
03.2016 - 09.2018
Masters in Engineering - Manufacturing Engineering
CSI Institute of Technology
Bachelors in Technology - Mechanical Engineering
Sarabhai Insitute of Science And Technology