Talented and accomplished manufacturing and process engineer with a proven record of facilitating corporate success by improving efficiency, quality, and productivity in manufacturing settings, particularly in the medical device and manufacturing sectors. Highly proficient at project management, cost estimation, product design and testing, process optimization, automation, quality assurance, and issue resolution. Excellent troubleshooting and supervisory skills. FDA and ISO regulations and standard proficiency.Specialties: Manufacturing Engineering, Process Engineering, Quality Assurance, Silicone Molded Products, Process Fixture Aids, Documentation, Inspection, Optical Gauging, Product Redesign Cost Control, Design Controls, Lean Manufacturing, Process Validation & Qualification, IQOQ, TQM, Problem Solving, BOMs, & Cost Estimation documentation in compliance with ISO 13485 Quality Mgmt. System, ISO 2859-1 sampling plan & ISO 9001 Quality Mgmt. Requirements.I believe in the power of networking, that's why I am a LinkedIn Open Networker (LION). Please feel free to connect with me using my email address: mkacs777@gmail.com
Listed skills include Iso 13485, Medical Devices, Fda, Manufacturing, and 20 others.