Abe Fadakar

Own VMP project for “Athena Embolization Coil (AEC)" which is intended for embolization of neurovascular aneurysm. Own Calibration and preventive matrix development Project. Plan and perform process, product and equipment verification and validation; IQ, OQ, PQ and PPQ's FMECA to comply with ISO and FDA design control requirements. Develop and coordinate the creations of technical files and design dossiers for approval of legacy equipment for addition to VMP

Performed manufacturing and facility equipment requirement gap analysis of the quality systems to identify gaps for improvements.Collected and analyzed data from different KPIs (Key Process Indicators) and presented them to management and annual reviews to ensure appropriate actions can be taken to correct and/or improve the non-conforming issues. Prepared site for FDA and internal audit, by performing internal/external audits; generated CAPAs and provide guidance

Guided teams to plan and perform product verification and validation; IQ, OQ, PQ review for Abbott’s Laboratory , production , and Packaging Equipment. Provided feedback and solutions for any gaps found to comply with ISO standards and FDA regulations and Abbott corporate quality systems. Served as the technical expert on all validation protocols submitted to QA for IQ, OQ and PQ approval. Analyzed validation activities and performed analysis the protocols. Assisted teams in preparing risk assessment

Planned and performed software & equipment validation by writing and executing protocols (IQ, OQ, PQ), wrote final reports and submitted to QA director for Boston Scientific’s iLab ultrasound imaging system with the Ultra ICE catheter with DICOM software. Developed and conducted software HACCP risk management plans: Fault tree analysis, Hazard analysis, FMEA, FMECA, User interface, Compliance testing requirements

development of quality system policies and procedures for ISO regulated environments for new “Class III” device . train responsible personnel to comply with ISO 9001:2008, ISO 13485:2003 (QMS) to obtain registrations and certifications at the headquarter in San Jose and its manufacturing facilities in Costa Rica.Design/development controls and manufacturing of the device from R&D phases into full production cycles

Performed stages from the incoming, in-process and final inspection and testing to release of “Class III” vascular surgery medical device. Analyzed the qualification data with respect to the pre-defined acceptance criteria, generated and resolved protocol deviations/discrepancies as needed and authored final protocol reports. Audited/evaluated line product/process and reported non-conformance and possible CAPA’s.

Prepared collection and analysis of all data for the “Class II & III” Devices for relocation to manufacturing facilities in Puerto Rico. Supported the transfer and foreign language conversion of all validation and verification documents. Monitored operations to ensure compliance to written procedures and/or the creation of regulatory requirements, issuance, tracking, review, approval, and/or control of transferring labeling materials; issuance, tracking, and control of LHR and data binders;

R&D Development

ASQ certified Quality System Audito

Pharmaceutical Engineering

Fashion Design/ Textile and Clothing