1. ISMAEL RODRÍGUEZNÚÑEZ
E-mail:irodri03@hotmail.com
Phone:656.611.0262
Mobile:044.656.638.4692
OBJECTIVE To obtain a challenging position in a high quality environmentwhere my resourceful
experience and academic skills will add value to organizational operations.
SKILLS & ABILITIES Knowledge ofprocess validations (IQ,OQ, PQ). Strong experience to develop and validate
test methods. Certified in ISO 13485 (Medical devices) and other regulatoryrequirements,
FDA regulatory requirements (GLP,GMP/QSR), Risk Managementconcepts
(Investigation/Documentation/actions to be taken), statistical process control,and statistical
problem solving.Strong knowledge ofLean Six Sigma/Process Excellence tools and
methodologies. Strong experience in Siebel system.
Good organizational skills, abilityto prioritize multiple commitments and technical problem
solving duties,abilityto collaborate with all levels of managementin cross -functional team
environment.
EXPERIENCE
NEW PRODUC INTRODUCTION QUALITY ENGINEER at Lake Region Medical 2015-
Present.
Quality leader responsible to transfer new projects from differentsites.Create drafts and
execute IQ/OQ & PQ. Perform process capabilitystudy to new manufacturing lines.
Design/execute new testmethod validations (TMV). Responsible to maintain functionallylive
documents such PFMEAS/DFMEAS/ Hazard list/ Work Instructions.Prepare and present
the Quality Metrics to Quality boar
SR. QUALITY ASSURANCE ENGINEER at Cordis de México S.A. de C.V.
2005- Present
Draft, review, and assist in the implementation of validation protocols, final validation
reports, Quality System procedure, Performance Qualifications, Engineering Change
Orders. Participate in development, review, and improvement of the manufacturing’s line
Quality Plan and processes. Perform investigations into product complaints and prepare
reports for review by Quality Manager prior to submittal to Corporate Quality Systems.
Analyze process, work operations, quality records, complaints, and other sources of data to
identify existing and/or potential causes of failures. Use appropriate statistical methodology,
such as CpK and trend analysis, to assist in analyzing or reviewing manufacturing, quality,
and/or laboratory data for recurring problems or the detection of negative trend. Establishes
reports and procedures in conjunction with Process Engineering to assure system reliability
and product quality. Design and implement methods and/or procedures for inspecting,
testing and evaluating the precision and accuracy of products and/or production equipment.
Participate lead the Audit Team in performing internal audits. Responsible for performing
design reviews and pre-validation assessments to ensure the safe and environmental sound
start-up of new processes. Participate in product transfer and changes. Implement error
proofing in critical processes. Responsible to maintain functionally live documents such
PFMEAS/DFMEAS/ Hazard list/ Work Instructions. Prepare and present the Quality Metrics
to Quality board.
FAILURE ANALYSIS ENGINEER
Work with Quality and Manufacturing group to identify root cause of field return product
failures.Implementcorrective and preventive actions.Identify root cause and modes of
failure,analyze and presentresults along with recommendations in a detailed and clear
report.
QUALITY & CUSTOMER SUPPORT ENGINEER at TRIGEM DE MEXICO S.A. DE C.V
2004- 2005
Managed quality engineering and process improvement projects. Supervised Quality

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Technicians. Lead quality internal and external audits. Supported and troubleshot quality
issues for different production lines (Gateway, Compact and HP). Provided technical
assistance when electrical or engineering problems were encountered before, during and
after assembling. Testthe new images from customer
ASSOCIATE PROCESS ENGINEER at DELPHI PACKARD ELECTRIC SYSTEMS
2003-2004
Provided technical supportfor routine manufacturing.Trained associates on operational
procedures.Performed assemblyline balancing process.SupportEngineering changes and
Model changes.Updated PFMEAs.
EDUCATION UNIVERSIDAD AUTÓNOMA DE CIUDAD JUAREZ, CD. JUAREZ, CHIH.
BACHELOR OF SCIENCE IN INDUSTRIAL & SYSTEMS ENGINEERING
Pursued graduate-level coursework in Business Administration atInstituto Tecnológico y de
Estudios Superiores de Monterrey, campus Ciudad Juárez.
COMMUNICATION Excellent verbal and writing communications skills to make oral presentations and write
technical reports. Ability to solve practical problems and deal with a variety of variables in
situations where limited standardization exists.Ability to interpreta variety of instructions
furnished in written,oral, diagram,or schedule form.
QUALIFICATIONS &
CERTIFICATES
KT Analysis (Problem Solving & Decision Making) Accreditation Certificate
ISO 13485 Accreditation Certificate