Senior Executive
CurrentMedical 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.