Oscor Inc.Quality Engineer
Jul. 2015 - May. 2019• Remediation team leader for quality system. • Work with engineering, operations, regulatory, sales/marketing, and quality to identify what is changing and if the customer is required to be notified.
• Technical knowledge on shipping labels
• Create Document Change Request and New Document Request (ECO)
• Create Product/Process Change Notice
• Communicate with customers
• Review and update procedures for quality for Corrective and Preventive Actions, Supplier Qualifications, and • Work with sales/marketing to create forms and reports for sales
• Create and conduct training on procedures and product flow diagrams
• CAPA system owner, updated system to make user friendly
• Received training on biocompatibility testing per what standard?
• Review CAPAs for completeness
• Closed over 100 CAPAs in 6 months