Lean Black Belt
Resume:
HILDA MORALES
***** ******** ****., ***. ****
San Antonio, TX 78260
915-***-**** Cell, 210-***-**** Work
***********@*****.***
CAREER SUMMARY
Industrial Engineer with 20+ years in Manufacturing, Research and
Development, and Quality including extensive experience in Medical Devices
Class I and II. Demonstrated technical expertise in new product
development/commercialization, design change verification, process & design
validation, and quality systems.
Core Competencies:
Leadership Team Training/Development
Internal/External Compliance Lean, Six Sigma Certifications
Quality Assurance Process Engineering
Customer Service Bilingual: Spanish and English
PROFESSIONAL EXPERIENCE
KIMBERLY-CLARK COPRPORATION, San Antonio, TX Mar 2013-Present
Quality Engineer/Process Engineer
Provide leadership to a team providing support for the visual and physical
inspection, sampling, testing, and control of products and materials.
o Manage the Customer complaint process, Device History record
investigations.
o Maintain and demonstrate knowledge & skills on the Quality Regulatory
for Medical Devices OTC.
o Responsible for Validation on new products or processes, modifying
fit, form, or function. (MVP, IQ, SQ, OQ, & PQ).
o Assure compliance to internal and external standards of FDA 21 CFR 820
and ISO 13485:2003 for medical devices.
o Perform Gaps assessment on Quality systems and develop action plans to
ensure compliance with Regulations and Standards.
o Provide consulting and training on key quality processes, tools, and
systems.
o Maintain and continue development of the non-conforming product
process.
o Provide process engineering support on resolution of process and
equipment problems
KCI/ARJOHUNTLEIGH, San Antonio, TX May 2011-Mar 2013
Sr. Industrial Engineer
Developed methods and operation sequences for the fabrication of parts,
subassemblies, and final products.
o Utilized company-wide ERP system to drive accurate manufacturing cost
estimates, shop capacity, and analyze production cost variances
o Ensured production methods were established correctly working closely
with the Scheduler/Planner.
o Responsible for new product introduction projects
o Acted under general supervision of the Manufacturing Engineering
Manager on multiple assignments of moderate scope and complexity and
independently solved problems and implemented solutions in the
manufacturing environment
o Responsible for charting projects and managing needed resources to
complete transition successfully.
J&J ETHICON ENDO SURGERY, Juarez (Mexico) Apr 2001-Apr 2011
Lean Coordinator (2004-Apr 2011)
Lean Implementation on 2 Facilities: Lines Reconfigurations, Processed
Excellent and Continuous Improvement and Coordinated Site Managers to
prepare for J&J Lean Maturity Assessment. Site achieved Integration Level
of such Assessment on April 2010.
o Trained and developed a team of six highly committed associates in
lean tools to react, anticipate, and resolve problems proactively and
execute strategic projects. Coordinated 3 engineers and 8 SMEs to
support Kaizen teams at site level.
o Coordinated and managed Kaizen workshops. Improved Kaizen workshops
with effectiveness follow up integration, including CIP follow up from
Kaizen projects and link to NIM meetings
o Performed lean tools, training across the site. Developed material to
standardize programs across campus related to Kaizen methodology, lean
training for associates, and continuous improvement, including metrics
and monitoring processes.
o Lead line reconfigurations to integrate lean concepts.
Sr. New Product Integrator (Apr 2001-2004)
Oversaw quality development systems and planning in support of R&D as it
related to manufacturing, distribution, and sterilization functions.
o Responsible for the transfer of design intent and product knowledge to
the manufacturing site in Mexico to assure an accelerated
manufacturing pilot attainment and transition to a steady state of
manufacturability of new product design platforms.
o Evaluated engineering tests in support of validation programs.
o Validation experience on new products or processes, modifying fit,
form, or function. (MVP, IQ, SQ, OQ, & PQ).
o Experience managing Quality Systems to comply with the CFR 820.
o Utilized Process Excellence methodology and tools to identify and
implement improvement projects to reduce cost, eliminate scrap, and
improve quality.
o Provided specific manufacturing support and technical expertise to
transfers of new product.
o Troubleshooting support and corrective action support to steady state
operations when needed.
DELPHI (AUTOMOTIVE), Juarez, Chihuahua (Mexico) 1997-Apr 2001
Capacity Planning/Cost Estimating Engineer (Jan 2000-Apr 2001)
Quoted for potential business with customers in USA, South America, Europe,
and Asia for Transmission Sensors & Solenoids.
o Cost impact analysis for design changes in existing products and for
changes in the determination of equipment needed to produce a new
product.
o Determined capital and tooling investments needed to set up new cells
as well as determination of labor standards, manpower staffing, &
floor space impacts.
o Coordinated cost reduction program development.
o MTM analysis, Lean Manufacturing workshops, and PFMEA elaboration.
Validation Engineer (1997-1999)
Participated in the development of processes that met divisional
statistical requirements, from design phase through delivery to
Manufacturing Plant.
o Active coordinator during the preparation and validation runs at MTC
and Manufacturing Plants.
o Responsible for Equipment Release Checklist as installation support,
tooling, maintenance, and monitoring at the production equipment level
to ensure critical product and process according to Project Design.
TRAINING AND CERTIFICATION
Six Sigma Green Belt for Process Excellence Certification
Lean Black Belt Certification
Design of Experiments Certification
ISO14001
Potential Failure Mode & Effects Analysis & Control Plan Certification
Geometric Dimensional & Tolerances (GD & T)
Dale Carnegie Effective Communications & Human Relations/Skills for Success
Training
EDUCATION
Bachelors of Science in Engineering, Instituto Tecnologico de Chihuahua II
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