
Abe Fadakar
Werdegang
Berufserfahrung von Abe Fadakar
- 1 Jahr und 11 Monate, Feb. 2014 - Dez. 2015
Validation Engineer for Class III brain aneurysms and stroke
Medina Medical, Menlo Park, CA
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
- 1 Jahr und 11 Monate, Jan. 2012 - Nov. 2013
Project Manager for Class II Medical Device Manufacture
Bayer Diabetes Care, A1CNow+ Sunnyvale. CA
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
- 1 Jahr, Jan. 2011 - Dez. 2011
Validation engineer for eluting coronary stent system
Abbott Vascular, Santa Clara, CA
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
- 1 Jahr und 2 Monate, Sep. 2009 - Okt. 2010
Validation engineer for “Class III” surgical medical device
Boston Scientific Neurovascular Interventional Cardiology, Fremont, CA
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
- 7 Monate, Feb. 2009 - Aug. 2009
Quality engineer for “Class III” therapeutic surgical women's healthcare
Hologic, Redwood City, CA
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
- 9 Monate, Mai 2008 - Jan. 2009
Quality systems analyst for “Class II” vascular surgery medical device
EV3, Redwood City, CA
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.
- 9 Monate, Aug. 2007 - Apr. 2008
Quality systems analyst for cardiac surgery Device
Boston Scientific Cardiac Surgery, Santa Clara, CA
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;
- 2005 - 2006
Quality engineer for Aerospace and Defense
Esterline, Buena Park, CA
- 2004 - 2005
Validation/Verification for new API Botox manufacturer
Allergan, Irvine, CA
- 2003 - 2004
QA packaging analyst for medical device manufacturer
Biorad, Irvine, CA
- 2002 - 2003
QA production technician
Teva, Irvine, CA
- 1995 - 2000
Fashion/Graphic Designer
Disney, Burbank, CA
Ausbildung von Abe Fadakar
- Bis heute 10 Jahre und 6 Monate, seit Jan. 2015
MS Medical Product Development
San Jose State University
R&D Development
- 4 Monate, Feb. 2006 - Mai 2006
ASQ Quality System Auditor
UC Irving
ASQ certified Quality System Audito
- 2 Jahre und 4 Monate, Feb. 2003 - Mai 2005
Certificate/option in Masters for Pharmaceutical Engineering
Cal. State Fullerton
Pharmaceutical Engineering
- 6 Jahre und 4 Monate, Feb. 1989 - Mai 1995
Textile and Clothing
Cal. State Long Beach
Fashion Design/ Textile and Clothing
Sprachen
Farsi
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