Nadeem
Tiruchirappalli
Summary
Detail-oriented MDR Vigilance Specialist with strong skills in regulatory reporting, complaint handling, and CAPA management, ensuring compliance and enhancing operational efficiency.
Overview
10
10
years of professional experience
Work History
MDR Vigilance Specialist II
Medtronic Engineering and Innovation Centre
Hyderabad
06.2025 - Current
- Evaluating the complaints record to determine the reportability of the complaints and report it to various regulatory bodies such as USFDA, EU MDR.
- Intaking the complaints from the complainant and entering it into global complaints system such as GCH, Trackwise, salesforce and service max.
- Drafted investigation summaries based on findings from various investigative actions.
- Demonstrated the ability to build reports and prioritize work in order of importance & effectively meet deadlines.
- Allocated work tasks and prepared WSR reports, CAPA initiatives, and scorecards.
- Preparation of audit reports and other quality records for internal and customer audits.
PMS Analyst
HCL Technologies
Madurai
05.2021 - 03.2025
- Led team with effective decision-making and problem-solving skills to achieve project goals.
- Developed reports and prioritized tasks to meet deadlines and support project deliverables.
- Communicate with Customers on Project updates and Quality Oversight.
- Prioritizing customer requirements and building strong relationships with customer through effective communication.
- Attending regional meetings to review QMR metrics and improvement areas to meet business requirements.
- Recruited and deployed appropriate talent pool and ensured training compliance before deployment.
- Preparation of Monthly & Quarterly PMS report to track & trend signal.
- Track-Wise code blitz to identify areas for process improvement.
- Work with Regional Regulatory leads to understand regional regulatory requirements and gap assessment in complaint handling process.
- Conducted gap assessment to identify and correct invalid entries.
- Monthly meetings with Global operation team to review the findings and action items to ensure compliance.
Quality Assurance Engineer
Rane Engine Valve Limited
Pudukottai
11.2018 - 04.2021
- Performance monitoring of quality management system to ensure the effectiveness, efficiency through KPIs indicator and conduct the management review meeting as per the clauses.
- Collaborated with production team members to help the team produce high quality, cutting-edge products.
- Monitored customer feedback and reviews to determine product improvements and defects.
- Coordinated documentation for change control processes to ensure compliance.
- Monitored customer feedback and reviews to determine product improvements and defects.
Coordinate change control documentation and approval process. - Performance monitoring of quality management system to ensure the effectiveness, efficiency through KPIs indicator and conduct the management review meeting as per the clauses.
- Red bin analysis and abnormality handling, why-why analysis of customer complaints and internal
rejections with CAPA analysis. - Shop floor audit readiness, ensuring quality, production & process control, 4M change management systems, handling abnormality, 5S maintenance, Inventory audits and coordinating QCC to eradicate internal defects.
Graduate Apprentice Trainee
Rane Engine Valve Limited
Pudukottai
09.2016 - 09.2018
- Monitored inline rejections and eliminated internal rejections to improve quality.
- Identified issues, analyzed information and provided solutions to problems.
- Monitored process efficiency by plotting and analyzing monitoring charts.
- Carried out capability testing on all manufacturing equipment.
- Verified the quality of inline products.
- Supervised work of contracted employees to deliver work on schedule.
- Engaged in team-building exercises to enhance collaboration among colleagues.
Education
B.E - Mechanical Engineering
JJ College of Engineering And Technology
Tiruchirappalli01-2016
Skills
- Adverse event analysis
- Regulatory reporting
- Complaint handling
- CAPA management
- Risk assessment
- Audit readiness
- Root cause analysis
- Issue identification
- Data analysis
- Process improvement
- Documentation management
Timeline
MDR Vigilance Specialist II
Medtronic Engineering and Innovation Centre
06.2025 - Current
PMS Analyst
HCL Technologies
05.2021 - 03.2025
Quality Assurance Engineer
Rane Engine Valve Limited
11.2018 - 04.2021
Graduate Apprentice Trainee
Rane Engine Valve Limited
09.2016 - 09.2018
B.E - Mechanical Engineering
JJ College of Engineering And Technology