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Mobile (408)747-7646) [Indian recruiters, Please DO NOT call. Thank you] Portfolio; https://www.linkedin.com/in/abefadakar. Only available for permanent jobs.
Medical Device Regulatory/Validation/ Quality Engineer and Quality System Auditor
13 plus years of experience with increasing responsibility and a successful track record in quality systems, serving life science
industries. Assisted many clients to qualify and obtain FDA 510(K), ISO 9001, 13485:2003 certifications, MDD 93/42/EEC
and IVD 98/79/EC CE Mark. Developed policies and procedures for FDA and ISO regulated environments and use these
policies and procedures to train quality, manufacturing and test personnel to perform their tasks and comply with. Developed
and implemented HACCP and QSIT product and process verification/validation for both hardware and software for products’
commercialization. Developed and executed validation protocols for DQ, IQ, OQ and PQ for devices/software/process, within
the “V” medical device life cycle model and agile software development models. Developed procedures and conducted ISO
14971 risk management plan: fault tree analysis, FMEA, FMECA to comply with ISO and FDA design control requirements.
Achieving device immunity within IEC60601-1-2-3 magnetic field (Medical/electrical equipment safety standards), Developed
and coordinated the creations of technical files and design dossiers for EU CE Marks, FDA IDE’s, and 510k’s. Developed and
trained responsible personnel on complaint handling and CAPA procedures and manage these processes to comply with FDA
and EU reporting requirements.
Medina Medical, Menlo Park, CA. February 2014 – December 2014
Validation Engineer for Class III Medical Device Manufacture and innovator of minimally-invasive devices for the treatment
of brain aneurysms and stroke.
•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 and designing testing the critical function test
methods for validation protocol and writing /circulating the final protocol reports for approval.
•Work with all groups and serve as the technical expert on all VMP activities and perform Gauge R& R activities.
Bayer Diabetes Care, A1CNow+ Headquarters, Sunnyvale, CA. January 2012 – July 2013
Project Manager for Class II Medical Device Manufacture
•Performed manufacturing and facility equipment requirement gap analysis of the quality systems to identify gaps for
•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 and external audits; generated CAPAs and provide guidance,
recommendations to suppliers, R&D, manufacturing, purchasing, materials controls to maintain closed loop corrective and
preventive actions to comply with FDA QSR, ISO QMS and other regulatory requirements.
•Developed a training program and trained responsible personnel to assist site for migration to blue mountain regulatory asset
management software.ISO13485 and device immunity with IEC60601-1-2-3 (Medical/electrical equipment safety standards).
IVDD 98/79/EC, MDD-EEC 93/42/EEC, FMEA (ISO 14971), FDA 21CFR part 820 medical device requirements. immunity
Abbott Vascular, Santa Clara, CA. January 2011 – December 2011
Validation engineer for “eluting coronary stent system” laboratory, production and packaging equipment.
•Guided teams to plan and perform product verification and validation; IQ, OQ, PQ review for Abbott’s Laboratory (HPLC’s,
autoclaves, freezers, refrigerators, ovens, incubators), production (compounder’s and Fillers), and Packaging Equipment (laser
labelers, packagers and boxers).
•Provided feedback and solutions for any gaps found to comply with ISO standards and FDA regulations and Abbott corporate
•Served as the technical expert on all validation protocols submitted to QA for IQ, OQ and PQ approval. Analyzed validation
activities and performed analysis to identify possible errors and offered guidance to correct the protocols.
•Assisted teams in preparing risk assessment for Lab-production and packaging equipment and the various facilities that house
the equipment. Worked specifically with Legacy equipment protocols and compliance with 21CFR part 11.
•Provided training on implementation of 21CFR part 11 for equipment’s including legacy systems.
Boston Scientific Neurovascular Interventional Cardiology, Fremont, CA. September 2009 – October 2010
Validation engineer for “Class III” surgical medical device
•Worked with team of five, 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, which resulted in the release the devices on time for Clinical Trials, 510k
IND’s and CE markings.
•Developed, documented and presented quality, manufacturing and test procedures for the device and used these procedures to
train quality, manufacturing and test personnel so that they can perform assembly, test and inspection of the device. Effective
implementation of all U.S. GxP regulatory authorities and 21CFR part 11electronic records/signatures
•IEC60601-1-2 Medical/electrical equipment safety standards; IEC 62304 medical device software life cycle. IEC 62366
usability, ISO 14971 risk management, ISO 9003:1997 supply of software in conjunctions with ISO 9001:2000 and
ISO9004:2000 bases for software validation, GxP regulatory authorities. Further more consistent with guidance provided by
the U.S. PDA, ISPE and the U.K. GAMP forum industry initiatives.
Hologic, Redwood City, CA. January 2009 – August 2009
Quality engineer for “Class III” therapeutic surgical medical device manufacturer for women’s healthcare
•Planned the development of quality system policies and procedures for ISO regulated environments for new “Class III” device
and used these policies and procedures to train responsible personnel to perform their tasks and comply with ISO 9001:2008,
ISO 13485:2003 quality management system (QMS) in order to obtain the company registrations and certifications at the
headquarter in San Jose and its manufacturing facilities in Costa Rica.
•Assisted R&D in the design development controls and manufacturing of the device from R&D phases into full production
cycles, such as creating design control phases requirements, Product specifications, performing risk management, Product and
process verifications and validations and commercial release requirements.
•Organized, established, monitored and continuously improved company quality management system and regulatory affairs to
accomplish ISO 13485:2003, CE Marks and full QA System certifications and developed and trained responsible personnel on
complaint handling and CAPA procedures.
•Performed internal and external audits; generated CAPAs and provided guidance, recommendations to suppliers, R&D,
manufacturing, purchasing, and materials controls to maintain closed loop corrective and preventive actions to comply with all
•Collected and analyzed data from different KPIs (Key Process Indicators) and presented them in management reviews to
ensure appropriate actions can be taken to correct and/or improve the non-conforming issues.
EV3, Redwood City, CA. May 2008 – January 2009
Quality systems analyst for “Class II” vascular surgery medical device
•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.
•Assisted QA manager in development, implementation and revision of procedures, files, records, and follow-up systems to
ensure processes are managed in a well-organized and timely manner.
•Researched, monitored and prepared semi-routine reports or analysis, summarized findings, and made recommendations, to
solve administrative problems.
Boston Scientific Cardiac Surgery, Santa Clara, CA. August 2007 – April 2008
Quality systems analyst for “Class II&III” cardiac surgery medical device manufacturer
•Prepared collection and analysis of all data for the “Class II & III” Devices for relocation to manufacturing facilities in Puerto
•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
•Monitored and verified qualification and validation of equipment and tools to be shipped.
•Performed inspection and release of equipment, supplies, manufactured products, raw materials and/or chemicals, before
•Reported, to QA manager, all deviations observed during the transfer processes.
Thermofisher Scientific, Fremont, CA. January 2007 – July 2007
Quality systems auditor for “protein-based” drugs Manufacturer
•Managed the Internal and External Audits; generated CAPAs, provided guidance and made recommendations to suppliers and
manufacturing, purchasing, materials and design control to maintain a closed loop corrective and preventive actions to comply
with FDA QSR, ISO QMS and other regulatory requirements.
•Developed and prioritized an auditing schedule and performed internal quality audits in support of ISO, CMDR, FDA and
OEM contract quality system regulations.
•Prepared the site for FDA and 3rd party audits and planned and assigned responsibilities to deal with audits.
Esterline, Buena Park, CA. February 2006 – December 2006
Quality engineer for Aerospace and Defense
•Analyzing and developing new web base corrective action software to provide a methodology for obtaining and documenting
all process that assures the root cause of a non-conformance is identified and corrected per Esterline quality assurance program.
•Performing internal audits and providing reports to QA Director. These activities include investigation of methods and
procedures to aim at finding more efficient and effective means of carrying out private and government contractual
responsibilities. Supporting quality assurance engineering functions on Aerospace and Military programs to include; quality
assurance test, inspection and program plans and procedures. Reviewing manufacturing and design engineering documentation
to ensure it contains the necessary quality assurance and customer provisions.
Allergan, Irvine, CA. July 2005 – February 2006
QA analyst for new API manufacturer
•Performed a wide variety of activities to assist QA supervisor in ensuring compliance with applicable GXP requirements.
Assured all documents were recorded in compliance with U.S., European and world wide regulations.
•Wrote, revised and reviewed SOPs and related manufacturing documents. Also, supported other team members with various
project developments by providing quality oversight of their development activities. Worked to resolve documentation
discrepancies. Managed QA archive document system for batch records.
•Performed instrument calibration and qualification (Pipettors, scales, fume hood, centrifuges, pressure/flow/temperature
sensors and microscopes), Temperature mapping (autoclaves, freezers, refrigerators, ovens, and incubators). Maintained
material control, qualification, segregation and tracking.
Biorad, Irvine, CA. September 2004 – July 2005
QA packaging analyst for medical device manufacturer
•Provided In-process quality control (IPQC) checks and sampling of in-process and finished product. Recorded all data
observations and other pertinent data to ensure cGMP compliance with respect to drug appearance, weight variation, friability,
hardness, disintegration, fill content, sealing, batch coding details and Bar code verification.
•Verified documentation and controlling of all Packaging activities with respect to line clearance, identity, drug appearance,
AQL checks and reconciliation.
•Approved product release by review of all documentation relating to the Manufacturing, Packaging & analysis and reports of
each batch of product to ensure accuracy and full compliance with cGMP and SOP’s.
•Reported all deviations observed during the inspection process to the QA manager.
•Prepared check list for each batch of product and ensured that all documents are in batch file.
•Reviewed all manufacturing, packaging records and analytical reports to ensure that they were complete and accurate.
Teva, Irvine, CA, February 2002 – September 2004
QA production technician
•Inspected the packaging/labeling equipment, vial and box labelers and plastic shrink wrappers to ensure compliance to written
protocols, and regulatory requirements, as applicable.
• Performed packaging production line clearance, inspection and release of equipment, supplies, manufactured products, raw
materials and/or chemicals, before shipments.
•Visually inspected the products and labels during labeling operation ensuring readability and attachment.
•Performed batch record reviews before submission to QA manager for approvals.
MS Medical Product Development Management, San Jose State University MAY2017
ASQ Quality System Auditor MAY2006 (FEB-MAY 2006)
Certificate/option in Masters for Pharmaceutical Engineering, Cal. State Fullerton, MAY2005 (FEB 2003-MAY-2005)
Biotechnology Laboratory Technician, BioHealth College, San Jose MAY2013 (JUN 2012-MAY-2013)
B.A Textile and Clothing, Cal. State Long Beach MAY1995 (FEB 1989-MAY-1995)
AA & AFA in Fashion Design, LA Trade Tech MAY1992 (FEB 1990-MAY-1992)
IN-HOUSE TRAINING CLASSES PERFORMED
Regulatory Submissions: Devices & Diagnostics
ISO 9001/13485 Compliances
CER Testing & Monitoring
IEC60601-1-2-3 (Medical/electrical equipment safety standards)
IVDD 98/79/EC, MDD-EEC 93/42/EEC
FDA 21CFR part 820 Compliance
FDA/ISO Biocompatibility Testing
FDA HACCP & QSIT
IEC 62304 Medical device software life cycle
IEC 62366 Usability
ISO 9003:1997 supply of software
ISO9004:2000 bases for software validation
ISO vs. FDA Standards Comparison
FDA 21CFR11 Compliance
MDD 93/42/EEC & IVD 98/79/EC Compliance
Canadian Medical Device Conformity Assessment
ISO 14644 Clean Room Validation
ISO 14971 Risk Management FMEA
•Windows, Linux, Unix, Androids OS
•Java, Python, Assembly and Matlab
•Statistical Tools: Minitab17, IBM SASJMP9, SPSS and R
•SolidWorks 2015 with Simulink, Blue Mountain, Autodesk Products (AutoCAD/3DMAX/Maya, Auto- lips), Lightwave,
Adobe Creative- Suite, Corel X, Crystal Reports and Excel Graphic Charts
To contact this candidate email firstname.lastname@example.org