BSIAssessor
Apr. 2015 - Dec. 2018 12950 Worldgate Drive, Suite 800 Herndon, VA 20170 • Maintain and develop assessment-skills, technical and management system standards
• Lead encouraged and coached colleagues as needed; establish effective partnerships
• Recommend the issue, re-issue or with-drawl of certificates and recommend opportunities for improvement, plan, schedule, budget and prompt information to support services
• Prepare assessment reports and approve corrective active and preventative action plans
• Oversee managers and suppliers ensure processes are operating efficiently, and objectives are met
• Supervised and conducted over sixty eight (68) Rx 360 Audits/ ISO Audits in the USA, Mexico, New Mexico, Italy, London, Brussels, Frankfurt and Ludwigshafen Germany, Netherlands, Belgium, Paris, Basel and Sisseln Switzerland, Luxembourg, Barcelona and Portugal, Dominican Republic, Puerto Rico, Guadeloupe, El Salvador, Panama City, Panama Budapest Hungary / certificates-ISO 9001:2015/ISO 13485: 2016, Certified in CMDCAS, IATA, TAPA (C-TPAT), ISO 22716:2007, MDR, MDSAP, EXCiPACT, EFfCI, ISO 14971, ISO 14155:2020, ISO 11135:2014, ISO 11137-3:2017, (GAMMA, EO, Steam), ISO 15378: 2017, IEC 62304, Food and (Medical Device Regulatory-in progress). Types of audits conducted supply chain security, packaging, active pharmaceuticals, excipients, cGMP, GDP, Raw Materials/Basic Chemicals and oil/gas. Conduct audits that consist of classification of medical devices, safety and effectiveness requirements, application for medical device licenses, foreign manufacturers, and obligation to inform, distribution records, recalls and implant registration data tracking, serialization, SAP and ERP systems. At least 300 audit days conducted and travel 100%.