I have been a Quality Assurance Manager in the Medical Device Field for the last 5 years. I have experience with management and implementation for the ISO 13485, ISO 9001, and 21 CFR Part 820 standards in relation to medical devices. I have assisted in getting multiple devices 510(k) certified with the FDA. I was in charge of training employees on Standard Operating Procedures and kept detailed logs of such training. I insured constant compliance to all QMS activities. I kept inventory of all products from vendors using a first in first out inventory system which I created. I have been directly responsible for customer complaint resolution, CAPA's and all product recall activities. I have built Product Specification Documents, and revised Formulation Specifications for multiple medical devices. I've reported directly to the CEO, and worked in conjunction with the production supervisor to ensure the highest level of compliance and productivity on the production line.
Quality Assurance, Medical Device, Quality Audits, Product Development, Risk Analysis, Customer Complaint resolution, Product Recall, Inventory Management, CAPA implementation and resolution, ISO, Management, Marketing, Management Review Meetings, Sales
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