Job Title: Manager, Operations & Quality
Job Location: Vivorté, Inc., Louisville, KY
Job ID: 667633771
Ensure all medical device design documentation is in compliance with current requirements and meets required submission standards for approval by Federal Drug Administration (FDA), International Standards Organization (ISO), American Association of Tissue Banks (AATB); Ensure lab and cleanroom policies and procedures are met as required by Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations; Utilize experience in medical device development and device manufacturing process engineering to support product development and commercialization; Oversee manufacturing transfer from Research & Development (R&D), scale up, validation, production and order fulfillment of the Trabexus Family of products; Implement design for manufacturability and cost containment processes; Work closely with marketing and sales to ensure proper inventory levels are in place and orders are filled accurately and timely; Ensure supplier quality program is compliant; Supervise process and quality engineers and technicians; Mange manufacturing facilities, tools, and equipment; Responsible for purchasing and supplier management including identification and qualification of suppliers and relationship management; and perform other quality functions as required. Supervise two subordinate employees: Process Engineer and Manufacturing Coordinator. Occasional travel, domestic, 2-3 times per year for supplier visits and/or trade shows.
Education: Master’s Degree or foreign equivalent in Bio-engineering or Biology.
Experience: 2 years of experience as an Associate Engineer or Research Assistant. The 2 years of experience must include a minimum of two (2) years of experience in the following: Working in a medical testing and research and evaluation laboratory on FDA 510K implantable device preparation and submission with implantable medical devices and biologics; Working with and in processing of allograft or xenograft issue; Drafting and submitting final test protocols and reports to be submitted to the FDA in our 510(k); and Working on products that are regulated by the FDA under a Quality Management System.
Apply for this Job: Please respond to Ruth Voor, Chief Executive Officer, by fax 1(502)805- 0721.