Retired from B. Braun Medical Inc.

Management Representative, Head of Quality & Regulatory function, also in-charge of HR and Procurement functions. Successfully formulated Policies, Procedures, Work Instructions and Forms to comply with Internal QMS, all the regulations and requirements of ISO 13485, FDA 21 CFR, MDSAP (CMDCAS, TGA, ANVISA, MHLW PAL etc) participating countries. Completed various projects, UDI, GUDID, TQM, CAPA, cGxx etc. to improve quality and effectiveness of all the operations within the company. In view of… Show more Management Representative, Head of Quality & Regulatory function, also in-charge of HR and Procurement functions. Successfully formulated Policies, Procedures, Work Instructions and Forms to comply with Internal QMS, all the regulations and requirements of ISO 13485, FDA 21 CFR, MDSAP (CMDCAS, TGA, ANVISA, MHLW PAL etc) participating countries. Completed various projects, UDI, GUDID, TQM, CAPA, cGxx etc. to improve quality and effectiveness of all the operations within the company. In view of past experience, picked up additional responsibility of Quality Control & Assurance, Human Resource Policies & Compliance as well as Procurement, including Supplier Quality Management. Show less

Completion of Review and Assessment of 75+ supplier files, preparation of supplier qualification reports based on supplier's criticality classification, priority, complexity of operations etc. and identifying gaps and developing priority based action plan as a part of FDA 483 remediation action protocol.

•Develop a Plan for conducting Internal Audit of various functions / departments of Ethicon, conduct the audits, issue NCRs, follow up through closure, report and update metrics.•Advise and support functional personnel on systems, procedures and routine activities in successful closure of NCRs and execution of other activities to be compliant with the standards and regulations. •Prepare and release weekly and monthly reports for pending and coming due action items associated with… Show more •Develop a Plan for conducting Internal Audit of various functions / departments of Ethicon, conduct the audits, issue NCRs, follow up through closure, report and update metrics.•Advise and support functional personnel on systems, procedures and routine activities in successful closure of NCRs and execution of other activities to be compliant with the standards and regulations. •Prepare and release weekly and monthly reports for pending and coming due action items associated with completed audits. Follow up and support successful closure of all the actions in timely manner. Show less

Supplier Quality Engineer Philips Healthcare – Cleveland, Ohio 6/2014 – 8/2015• Working with CLE management to develop or procure necessary documentation to fill the identified gaps during FDA audit• Extensive on-hand experience with Risk Classification, Assessment, Evaluation and Mitigation• Managed to complete Product and Process Qualification for more than 150 parts purchased from suppliers within and outside the USA. • Performed evaluation of… Show more Supplier Quality Engineer Philips Healthcare – Cleveland, Ohio 6/2014 – 8/2015• Working with CLE management to develop or procure necessary documentation to fill the identified gaps during FDA audit• Extensive on-hand experience with Risk Classification, Assessment, Evaluation and Mitigation• Managed to complete Product and Process Qualification for more than 150 parts purchased from suppliers within and outside the USA. • Performed evaluation of parts using various Quality Assurance tools including PFMEA, Control Plan, FAI, Special Process Validation, MSA, GR & R, FAIR, LAR, ECR, ECO, SCR etc. • Supporting SQM team with required documentation for FDA audit remediation plan • Working aggressively among a team of SQEs and cross-functional groups to develop a robust supplier oversight, monitoring and control system and effective employment of the tools• Closely interacting with Suppliers and helping them to prepare documentation that is compliant to the requirements of Philips Remediation Plan while strengthening and enhancing their QMS. • Learning operating systems, procedures, regulations, way of working prevailing and forthcoming at Cleveland• Strong networking of internal customers with more than 50 suppliers developing and supporting business Show less

Ensure performance of more than 70 suppliers (11 key suppliers) towards maintenance activities to meet quality needs, and improve supplier performance and productivity. 1.Strategically plan, develop, promote, and implement programs designed to improve supplier quality performance, productivity and reduce overall costs. 2 Plan, organize, and report supplier performance metrics to provide key information to the department manager and other departments. 3.Participate in supplier… Show more Ensure performance of more than 70 suppliers (11 key suppliers) towards maintenance activities to meet quality needs, and improve supplier performance and productivity. 1.Strategically plan, develop, promote, and implement programs designed to improve supplier quality performance, productivity and reduce overall costs. 2 Plan, organize, and report supplier performance metrics to provide key information to the department manager and other departments. 3.Participate in supplier selection process and perform QMS review, line audits to evaluate supplier capabilities, quality systems, processes and services. 4. Perform qualification of supplier by periodic quality system audits and quality reviews to qualify overall quality of part / component manufacturing. 5.Ensure quality of incoming parts and participate in MRB process to resolve internal quality non-conformances. 6.Direct supplier root cause analyses and corrective actions to prevent recurrence of quality issues. 7. Collaborate with R&D, Engineering and Q & R to ensure that incoming product specifications contain and clearly communicate the requirements needed to ensure supplied products are acceptable for manufacturing and assist in the development of inspection methods and improve sampling plans for new materials and components. 8.Identify non-conformance trends; develop and administer technical investigations and corrective action programs to resolve recurring quality problems. 9.Provide technical assistance to suppliers to perform change management, qualification / validation testing. 10.Provide statistical support by creation of supplier performance metrics and identifying opportunities for supply chain improvements.11. Certified Lead Auditor for ISO 13485 QMS Show less

Led and completed various projects related to medium voltage switchgear involving Product and component review and improvements, Product field returns on RMA, complete investigation and issue reports to the management and customer, Product testing at KEMA Test lab in Netherland, and POWERTECH, and certification for UL, Manufacturing and Assembly process improvements, Work standardization, Material substitution, Customer complaints review and engineering reports, ISO 9001 Quality Audits… Show more Led and completed various projects related to medium voltage switchgear involving Product and component review and improvements, Product field returns on RMA, complete investigation and issue reports to the management and customer, Product testing at KEMA Test lab in Netherland, and POWERTECH, and certification for UL, Manufacturing and Assembly process improvements, Work standardization, Material substitution, Customer complaints review and engineering reports, ISO 9001 Quality Audits, Training for shop and field service personnel etc. Show less

Led the Switchgear Test Engineering Department for last 7 years to provide state-of-art automated test setups for routine testing of various products of the EBG. Worked in various functions for 18 years including Product engineering, Production Planning and Scheduling, Technical Marketing, Quality assurance, Application Engineering, Product Marketing, Field Surveys, for various electrical and electronic products for various consumers and industries.

Design and Product Engineering of Low Voltage Electrical Switchgear and Control gear. Sales backup. Shop support. Cost estimation for custom made switchboards and accessories.