Prabhu Raj
Process validation/Quality Engineer - Medical Devices
- Role
- Lead Engineer at HCLTech
- Location
- Coimbatore, TN, IN
- LinkedIn followers
- 500 followers
About Prabhu Raj
Led Manufacturing Transfer projects and Process Validation (IQ/OQ/PQ), closing gaps in Design CTQs, Control Plans, FAIR, and ensuring manufacturing readiness- Developed and maintained Control Characteristic Traceability Matrix (CCTM) and PFMEA documents to identify, assess, and mitigate process and product risks- Performed end-to-end complaint investigations and post-market surveillance, including Product Identification, CAPA review, Risk Assessment, and MDR submissions to the FDA- Collaborated with suppliers, manufacturing teams, and cross-functional stakeholders to validate documentation, implement solutions, and manage BOMs and Engineering Changes- Ensured compliance with ISO 13485, ISO 14971, 21 CFR 820, and global reporting standards (IMDRF), while maintaining Good Documentation Practices (GDP).
Experience
Lead Engineer
Nov 2025 — Present · Tamil Nadu, IN
Education
Sri Ramakrishna Engineering College
Bachelor of Engineering - BE, Biomedical/Medical Engineering
2015 — 2019
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