Conduct medical device, cosmetic and pharmaceutical excipient and APIs, and supplier certification, evaluation and qualification activities, including on-site and desktop assessments of quality systems, product and process controls develop control plans for monitoring supplier corrective actions for quality, performance and delivery, employing standard industry tools (pFMEA, root cause investigation, lifecycle management, purchase part approval process) determine receiving inspection plans and acceptance criteria, based on critical-to-quality product requirements ensure alignment with GHTF N17, ISO 9001 / ISO 13485 sec 7.4 and 21 CFR 820.50 Conduct QMS audits for chemical, manufacturing, packaging, labeling, manufactured components, contract lab and testing services, biologics, pharmaceutical and medical device organizations per ISO 9001:2008 / ISO 9001:2015 and ISO 13485:2003 / ISO 9001:2016 standards and QSR (21 CFR 820) and GMP (21 CFR 211) requirements Exemplar / RAB/QSA Lead Auditor certification for ISO 9001:2008 and ISO 13485:2003 EXCiPACT certified Lead Auditor - only qualified auditor for EXCIPACT in the Americas Trained in ISO 9001:2015 trained for ISO 13485:2016 * R�sum� - 2016 * * * * * * * * * * * * * * FDA 483 remediation for Supplier Quality Management issues at major CT and Nuclear Medicine equipment manufacturer Develop harmonized best practices, processes and procedures for supplier quality management for diverse global healthcare sector business groups and associated business units for top-tier European medical device company, based on global standards and worldwide regulatory requirements. Developed and managed design, manufacturing and quality documentation for medical device organizations and their suppliers. Quality Management System development and implementation for small medical device, biochemical and optics businesses. ISO 13485:2003 Lead Auditor and Internal Auditor certification through BSi. ISO 13485:2016 Lead Auditor training through NSF ISO 9001:2015 Lead Auditor training through SGS Thorough working knowledge of 21 CFR 11, 21 CFR 58 (GLP), 21 CFR 111 (dietary supplements), 21 CFR 211 (GMPs), 21 CFR 600, 21 CFR 606, 21 CFR 660, and 21 CFR 820, 93/42/EEC, 98/79/EEC, CMDRs Well-versed in ISO 14971 Risk Management, FMEA, FMECA, fishbone, DMAIC, PDCA, 5 Whys, Fault Tree Analysis, etc. Developed ISO 9001:2000 and QSR-compliant document management system for major clinical chemistry device manufacturer Compiled, developed and/or submitted 510 (k) and technical files for regulatory approvals for software (embedded and system-level) and electro-mechanical medical devices Martin J. Webster
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