Senior Quality Specialist - (Fort Worth, TX)

Job overview Key functions: Implements the quality management system and ensures functional compliance to the applicable FDA, MHRA, EUDRALUX, and international standards for cGMP and GDP plus state qualifications. (Smith & Nephew Fort Worth Manufacturing and outsourced contract manufacturing suppliers). Develops policies and procedures for management of Fort Worth Manufacturing and outsourced supplier's compliance related to manufacturing, packaging, method, sterilization, etc. for Smith & Nephew products. Assesses and approves departmental Standard Operating Procedures within the Electronic Document Management system to ensure content complies with the established Quality Management System. Leads activities within the quality area related to Change Control, CAPA, Deviation and Nonconformance investigation, product complaint handling, issue solving, trending, etc with suppliers and CMO's. The Senior Quality Specialist provides guidance to the Quality Specialists and other associates.