Pritam Mondal
Medical Device QA Engineer | ISO 13485 & 21 CFR 820 Expert | CAPA & Post-Market Surveillance (PMS) Specialist | Risk Management Enthusiast | Driving Patient Safety Through Quality Engineering | ex-Wipro
- Role
- Quality Assurance Engineer at Stryker
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Pritam Mondal
Quality Engineer | PMS Specialist | Biomedical Expert | Regulatory Compliance Champion…
Experience
Quality Assurance Engineer
Apr 2024 — Present · Gurugram, IN
Driving excellence in medical device quality through end-to-end customer complaint investigation and risk management. Experienced in handling global complaints from APAC, EU, North & South America, USA, and Canada, ensuring compliance with regulatory standards (ISO 13485, ISO 14971, FDA 21 CFR Part 820, MDR).Key Contributions:1. Led customer complaint investigations, including patient/user injury or harm cases, with thorough root cause analysis and reportability determination.2. Spearheaded cross-functional collaboration with service, R&D, regulatory, and manufacturing teams; co-led customer site visits with the Service Team to resolve product issues.3. Developed and deployed Power BI dashboards to monitor intake volumes, track team performance, and drive data-driven decision-making.4. Executed RAA remediation, risk file remediation, and hazard identification for legacy and new products.5. Conducted complaint trending and nonconformance (NC) investigations, supporting CAPA planning and execution as a subject matter expert.6. Applied risk management principles (ISO 14971) in evaluating product safety and mitigating hazards.7. Supported Computer System Validation (CSV) activities to ensure compliance and reliability.
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