Medical devices professional ISO 13485:2016, ISO:9001, ISO 10555Medical devices back ground of #PTCA,PTA,TAVI, Sinusplasty balloon catheter product.#Stent Lasar cutting,Stent Electropolishing,Stent pre cleaning,Stent Drug coating and Stent crimping on balloon.#ETO sterilization Process 1.Supervises production operations and work to meet production goals.2.Responsible for production planning and production schedule.3.Coordinate with FG department and RM department for stock availability.4.Responsible for training of new joiners.5.Responsible for work allocation to manpower.6.Responsible for validation of critical process with QA 7.Responsible for quality of finished goods.8.Overall responsible for timely closure of NCR/CAPA/Deviation/Internal audit observations/external audit observations/market complaints.9.Responsible for overall QMS compliance.10.New vendor development and validation of material.11.Responsible to product development and improvement.12.Responsible to Utility area.13.Responsible of Quarterly employees evaluation and rating.14.Prepare of monthly MRM data.15.Coordinate with supplier.16. Control documents modification work.e.g. SOP, MFC,BMR,BPR.17.Knowledge about ISO13485:2016 medical devices quality system.18.Knowledge about Kaizen and 5S system.

As a project leader, I have set up the Balloon Catheter Plant on behalf of sahajanand medical technology limited at Vascular Concepts Limited Bangalore.

Medical devices professionalPTCA,PTA balloon catheter product 1.Supervises production operations and work to meet production goals.2.Responsible for production planning and production schedule.3.Coordinate with FG department and RM department for stock availability.4.Responsible for training of new joiners.5.Responsible for work allocation to manpower.6.Responsible for validation of critical process with QA 7.Responsible for quality of finished goods.8.Overall responsible for timely closure of NCR/CAPA/Deviation/Internal audit observations/external audit observations/market complaints.9.Responsible for overall QMS compliance.10.Responsible to product development and improvement.11.Responsible to Utility area.12.Responsible of Quarterly employees evaluation and rating.13.Prepare of monthly MRM data.14.Coordinate with supplier.15.Performed as a Internal auditor and audite.

Injection Molding ProcessMold material selectionMold designMachine TroubleshootingProduct development and improvement

Injection moldingProduction Planning Quality Control Quality assurance