1. Experience
Experience: Control Process
Engineer 4 years’
experience
Skills / Aptitudes
Processes
Skills: Design & Control Processes across Lean & Six Sigma Tools
Archievements: Standardize operations across work instructions and
operational training.
Increase the volumen of pieces across line balancing.
Reduce the thickness sealed variability through Anova&DOE,
having a process with a CPk of 1.33 four sigmas.
Implementation of TPM & SMED in sealers machines.
Monthly production record in the bags manufacturing
(1’000,000).
Costs Reduction (Materials-Labor)
Quality
Skills: Control Processes
Archievements: Yield reduction in the lines production across implementation
of control charts np- p
Education & Professional Qualifications
2000-2004 Bachelor’s Degree in Industrial Engineer
University of Guadalajara
Specialty in Quality Systems and Production
2008-201o Internal Course in Lean Manufacturing & Six Sigma
Lean Six Sigma Institute
Black Belt Certification
2010 External Course in Fundamentals of Injection
Careintra
2014 External Course AAMI (Association for the Advancement of Medical
Instrumentation) Quality System Regulation (21 CFR Part 820 “Legal
Requirement for manufacturers distributing medical devices in U.S.”)
2015 External Course ISO 13485:2012
Medical Devices
Industrial Engineering/Lean Manufacturing & Six Sigma
Gonzalo Alejandro Madrigal Gómez
San Juan Diego #36
45420, Tonalá, Jal. México
(55) (33) 36900551 Telephone
• (044)(33) 35978972 Cell Phone
@ amadrigal80@hotmail.com
Being an agent of change within the company, applying effective
leadership and teamwork to achieve continuous improvement in
processes to reach a common purpose for the growth of the company
Attributes
Discipline
Compromise
Responsability
2. Language
Native Language: Spanish
English: Level 80-90 %
At Proulex
Software
Microsoft Office. Advanced
JMP & Minitab. Advanced.
Others data
Profesional License. 5230095
Military ID. C- 3222342
2007-2010 PYMPSA Plastics & Raw Materials S.A.
Position: Quality & Control Process Engineer
Functions: In charge of the production lines of tube, film & lay flat extrusion, injection, sealing, assembly and
packing
Review of productivity indicators OEE
Daily, Weekly and Monthly fulfillment program
Line Balancing
Improvement and maintenance of Lay out.
Process Automation
Flow Process (Spaghetti Diagram)
Statistical process validation (IQ, OQ, PQ)
Product Released (Product in process & Finish product)
Non-conformance product in raw material, product in process and finish product
Process control for the output variable thickness in the bag Cpk.
Management of NOM 059, ISO 9001, FEUM.
Tools Lean Manufacturing.
OEE, 5´s, Andon, VSM, SMED, Celular manufacturing, TPM, 8’D, CTQ, AMEF, Control Plan.
Tools Six Sigma.
R&R, Control charts, Normality Test, CPk, ANOVA test, DOE, DMAIC
Chief: Eng. Moisés Linares Telephone. 36685959
2006-2007 EPT Emerson Power Transmission
Position: Planner Scheduler
Functions: Report and monitor production schedules
Product shipment tracking (by air-by ground)
Released of program to the supervisors
Monitoring products in Stockout, OEM & Backlog
Expedite product with the CSR
Review the shorcuts of materials
Review the demand & Forecast of the products to released daily program
Chief: Eng. Víctor Corona Telephone. 36880024 Ext. 216
Gonzalo Alejandro Madrigal Gómez 10 years of experience
Professional Experience
2016 JABIL ADVANCE MECHANICAL SOLUTIONS (Current)
Position: Sr. Quality Engineer
Functions:
Release product in process & Finished Good
NPI
FMEA, QCP
PPAP
APQP
CARs (8Ds)
2012 – 2016 FRESENIUS MEDICAL CARE
Position: Sr. Quality Engineer & Statistician
Functions:
Management in NOM 059(GMP), 21CFR210 & 820, ISO 13485
Management Review Administrator
Control Charts Implementation for the lines Liquid Acid, PD, Saline Solution & Sodium Citrate
Trending Analysis in all areas of the plant
Readiness and reception for FDA & COFEPRIS Audits
Establishes, maintains, and directly manages Statistical Techniques and Monitoring of Quality Data
programs. This includes but is not limited to statistical methods, sources of quality data, analysis tools to
comply with regulatory requirements and improve business performance.
Collaborates across all functions to identify emerging trends in quality data using both statistical and non-
statistical tools.
Establishes necessary processes that determine the most appropriate sources of quality data to be
monitored. Ensures the most relevant data is available to site management for assessments.
Contributes to investigations for threshold excursions and general problem solving associated with data
monitoring activities.
Evaluates and contributes to the implementation of risk techniques to determine escalation requirements
when quality issues and/or emerging trends are detected.
Provides statistical techniques support to functional groups in the organization as needed (design control,
validations, inspection, etc).
Processes large amounts of data for statistical modeling and graphic analysis using electronic software
tools
Assists in statistical software and spreadsheet validations related to the use of statistical techniques and
quality data monitoring.
Defines appropriate AQL’s and sampling plans used throughout the site, and ensure they are established
with the appropriate documented rationale.
Remains current on technical/technological advances and contemporary thinking in the Statistics/Data
Monitoring fields as they are applied to the medical device industry.
Establishes necessary training modules for and train personnel on the proper use and application of
statistical methods used at the site.
Provide assistance to lower level staff with general tasks that require a better understanding of functions, as
directed by immediate supervisor.
Reviews and complies with the Code of Business Conduct and all applicable company policies and
procedures, local, state and federal laws and regulations.
Professional Experience
2011-2012 IBM OF MEXICO
Position: QE Quality Engineer & Procurement Quality Engineer
Functions: Administrator of the Assembly-Packing Autoloaders line
Review and analyze the productivity indicators Yield (líne-suppplier)
Yield Reporting Inter-company (Gdl-San Jose)
Root Cause analysis for customer complaints (Hot line)
Management of ISO 9000 & 14000
Lean Manufacturing & Six Sigma
Improvements Continuous Team (Mudadori)
Field Return analysis
Control Charts Implementation for the Assembly line
Process audit tracing for ISO 9000 audits
Chief: Eng. Agustín Solís Telephone. 36697000
2010-2011 ZF SACHS
Position: Sr.Process Engineer
Functions: In charge of Welding, Assembly and packing line of shock absorbers
Review of productivity indicators OEE /TRS
Fabrication and maintenance of tooling
Line Balancing
Review the preventive maintenance in the machines
Monthly fulfillment of the goals
Find the window process in the machines (Parameters)
Elaboration of work instructions (HCO)
Process Control for the output variable Compression-Traction of the shock absorbers Process
Capability CPk
Implementation & tracing of the APQP
Process Validation PPAP
Management of TS 16949
Chief: Eng. Martin Castellanos Telephone. 32080000
