Description
BSI ISO 13485:2003 Lead Auditor (TPECS) Certification - Certificate: 7930649-76913 * Hired and entrusted by B Braun McGaw of Puerto Rico and LeMaitre Vascular to implement a wide-array of corrective actions and systems resulting from 3 FDA warning letters. Subsequently after new systems implementation received 0 FDA 483 observations for a combined period of 12 years. * Built company-wide shared quality visions which completely transformed the quality culture and mind-set across six (6) organizations in the USA Puerto Rico and Internationally with successful consolidation of Quality Systems for plants located in the USA Puerto Rico and Internationally. * Provided strategic guidance and leadership in building and improving Quality Management Systems for compliance with 21CFR 820 (QSR) 211 (Pharmaceuticals) ISO 13485 and Canadian GMP for plants in the USA Puerto Rico and Internationally. * Building of comprehensive systems for supplier approval alliances change management supplier audits supplier corrective actions and Quality Agreements for plants in the USA Puerto Rico and Internationally. * Lead and implemented cost improvement programs and Lean Initiatives to achieve cost reduction projects that achieved more than $1.5 million in operational savings and reduced Release Cycle Times by more than 75%.. * Lead and executed more than five due diligence audits related to new product lines and company acquisitions. * Lead complaint investigations and/or failure investigations on products and processes which resulted in the elimination of root causes and the reduction in investigations and complaints by more than 50%. Implemented and improved Sampling Plans Frequencies CAPA and investigation systems which facilitated the root cause elimination of repetitive non-conforming events and customer complaints by 90% and reduced by 90% product rejects.
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