Diana Lourdes Santiago-Torres has over 20 years of experience in quality engineering, process validation, and computer system validation. She has worked at companies such as Medtronic and Merck Sharp & Dohme. She has a Bachelor's degree in Chemical Engineering and additional training in Lean Six Sigma. Her resume demonstrates experience leading projects, authoring documentation, and ensuring regulatory compliance.

1. D I A N A L O U R D E S S A N T I A G O - T O R R E S
690 CESAR GONZALEZ APT. 2007, SAN JUAN PR 00918
MOBILE (787) 245-0180 • E-MAIL DIANALOURDES@ONELINKPR.NET
OBJECTIVE
To obtain a competitive position in the quality/process engineering field in which
I could apply my skills, knowledge and experience on compliance, process
validation, and computer systems validation.
EXPERIENCE
OCTOBER 2014
– PRESENT
Medtronic (through ISO Group) Juncos, PR
Quality Engineer, Neuromodulation (Contractor)
 Collaborated with Manufacturing area to ensure quality systems and standards
are in place.
 Generated, reviewed, and approved change orders, quality records, and
manufacturing documentation.
 Provided support to the Synchromed Remediation Group special builds
project.
 Lead investigation on CAPAs.
 Participated in Kaizen exercises for OJT improvement.
 Provided training on quality issues to personnel.
 Collaborated in daily Tier 1 and 2 meetings with Neuromodulation
manufacturing team.
 Coordinated Quality-related activities in preparation for shutdown.
 Participated in First Time Quality exercises for Neuromodulation area.
2004 - 1014
Juan G. Santiago & Asociados, CSP - Insurance Brokers San Juan, PR
Administrative Manager
 In charge of Customer Service, Claim Processing, IT System Management, and
Office Management (including Payroll).
 Optimization of processes such as claim processing, SRO voucher processing,
among others.
MARCH 2014
Cobalto San Juan, PR
Independent Contractor
 Performed pre-UAT testing for two websites developed by the Company.
 Reviewed and improved UAT checklist to be delivered to the Customers.
1996–1998
Merck Sharp & Dohme Barceloneta, PR
Process Scientist, Factory 6
 In charge of compliance of quality (GMP), safety and environmental issues.
 Prepared and executed project plan for Computer Validation for Veterinary
Pharmaceutical Operations. Project plan consisted of:
 Inventory of all computerized systems for Factories 4 and 6
 Gap Analysis to determine requirements to be fulfilled according to FDA
and IEEE guidelines.

2. RESUME OF DIANA LOURDES SANTIAGO TORRES
PAGE 2
 Generation of QAP’s for every computerized system.
 Generation, revision, and approval of documentation, including SOP’s,
validation plans, and reports, among others.
 System Administrator for Automatized Systems and Equipment in Factory 6.
Some of the responsibilities included:
 Generation and execution of QAP, Validation Plan, and SOPs for new
purified water meter system.
 Supervised auditing and documentation operations at Factory 6 Manufacturing
area (3 employees).
 Prepared Product Annual Reviews.
 Reviewed and executed Operational Qualification and Process Validation on
new equipment and processes.
 Investigation of atypicals, including CAPA.
 Responsible of expediting weekly shipping commitments.
1991-1996 Merck Sharp & Dohme Barceloneta, PR
Site Trainer, Human Resources Department
 In charge of GMP training program for the site (~350-400 employees).
Prepared and executed project plan for Regulatory Compliance Training in
Puerto Rico Operations (~1100 employees).
 In charge of New Hire Orientation training.
 Certified as Principle Centered Leadership - Covey's 7 Habits of Highly
Effective People trainer. Prepared and executed project plan for the training
of 200 persons in 6 months.
 In charge of Technical training coordination for hourly employees (Training
for New Technology).
 Certified Trainer in Situational Leadership, Train-The-Trainer and Problem
Solving/Decision Making.
EDUCATION
2001–2003
University of Puerto Rico San Juan, Puerto Rico
Rio Piedras Campus
 Natural Sciences Undergraduate General Program (26 credits)
 Courses completed include Organic Chemistry for Chemistry Majors, Genetics,
Microbiology, & Statistics.
 Research work in Chemical Education Laboratory, developing computer-based
interactive modules on Organic Chemistry Lab Techniques, course web page
design & maintenance, and other lab work.
1986–1991
University of Puerto Rico Mayagüez, Puerto Rico
Mayagüez Campus
 Bachelor in Sciences in Chemical Engineering, Magna Cum Laude

3. RESUME OF DIANA LOURDES SANTIAGO TORRES
PAGE 3
 GPA: 3.54; member of the National Engineering Honor Society (Tau Beta Pi),
AIChE
 Undergraduate Research work in Hybrid Artificial Pancreas Laboratory,
performing diverse laboratory work including but not limited to animal care, rat
surgery, harvesting of pancreas cells, culture media preparation, in-situ
experiments.
1982–1986
Colegio Lourdes High School San Juan, Puerto Rico
 High School Diploma, High Honors
 One of the Top 100 College Board scores of fall 1985 examination.
ADDITIONAL COURSES AND CERTIFICATIONS
 PMP®/CAPM® Prep Course by PM Instructor (35 hours) – June 2014
 “MS Excel Formulas and Charts” by PM Instructor (8 hours) – July 2014
 Introduction to Lean Six Sigma by Polytechnic University of PR (7 hours) –
August 2014
 Lean Six Sigma Yellow Belt Certification by Polytechnic University of PR &
LaSalle Group – October 2014
PUBLICATIONS
 “Development of web-based laboratory modules for Organic Chemistry for
Chemistry Majors Course”
Presentation at ACS Jr. Technical Meeting, 2002, Arecibo, PR
 “Solute Transport in the Hybrid Artificial Pancreas”
Poster Presentation at AIChE Convention, 1990, Chicago, IL
 Solute Transport in the Hybrid Artificial Pancreas
Presentation at ACS Jr. Technical Meeting, 1990, San Germán, PR
SKILLS, INTERESTS AND ACTIVITIES
 Fully bilingual (English & Spanish), both orally and written.
 Computing and Web Page Design. Full knowledge of Microsoft Word, Excel,
PowerPoint, Publisher, FrontPage; Adobe Acrobat, Photoshop Elements, among
others.
 Expertise as manager in various social media platforms (Facebook, Twitter,
Foursquare, Instagram).
 Youth Ministry, Catechist, and volunteer work in Parochial Counsel, Parroquia
Sagrado Corazón (University Gardens) and Colegio Marista (Guaynabo)
 Secretary of the Board of Directors, Condominio Parque de las Fuentes (2002-2005).
 Scrapbooking (traditional and digital), genealogy, mosaics.
REFERENCES AVAILABLE UPON REQUEST.