Krishna Sethuraman
Certified CQI-IRCA ISO 13485:2016 Lead Auditor| Focused on continuous improvement and defect prevention | FDA | EU MDR | Medical Devices | Supplier Quality | Supplier Audits
- Role
- Senior Engineer at L&T Technology Services
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Krishna Sethuraman
Quality is never an accident; it is always the result of intelligent efforts.\"- John…
Experience
Senior Engineer
Nov 2021 — Present · Bengaluru, IN
Perform Process validation -(IQ, OQ, PQ)• Ensured timely identification, implementation, and monitoring of Corrective and Preventive Actions (CAPAs) for• non-conformances arising at any stage of the medical device lifecycle, including during internal/external audits or as a response to product complaints.• Conducted risk assessments within the Quality Management System (QMS) and recommended targeted process enhancements to improve compliance and operational efficiency• Process owner for supplier management SOPs and work instructions, enabling operational standardization.• Streamlined the supplier disengagement process by collaborating with multiple cross functional teams improving the disengagement efficiency by 30%.• Developed interactive Power BI Dashboards to enhance reporting, traceability, and productivity.• Preparation of risk management files for devices in accordance with ISO 14971:2019.• Prepared packaging stability reports by performing regression analysis on accelerated and ambient test data to validate product shelf life, packaging durability, and environmental resilience• Led a labeling project involving creation and review of medical device packaging labels, Instructions for Use (IFU), and Family Group artwork, ensuring accuracy, regulatory alignment, and appropriate application of CE mark under EU MDR guidelines.• Final review and approval of product labels.• Established technical file in accordance with MDR (INDIAN)-2017.• Prepared Device Master File for requirements related to devices.• Prepared SOPs and work instructions related to QMS. Monitored control of documents, data, and records of the company pre-training to the quality management system
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