Manufacturing Execution System
Maria Lourdes Castillo
Industrial Engineer
Santo Domingo,DN
Summary
Experienced Industrial Engineer with 4+ years in the manufacturing sector, dedicated to enhancing product quality and optimizing production processes. Demonstrated expertise in the qualification of products and processes underscores commitment to ensuring operational excellence. Recognized for a sense of urgency, results-oriented mindset, and unwavering dedication to responsibility, consistently delivering high-quality outcomes in a fast-paced environment. Passion for creative problem-solving drives pursuit of innovative solutions that streamline operations and enhance productivity. Whether devising more efficient workflows or implementing cost-saving measures, thrive on making work easier and more effective. Eager to immerse in new challenges, expand expertise across various domains, and ultimately ascend to leadership positions. Seeking stimulating work environment fostering continuous learning and growth, poised to make significant impact while pursuing professional aspirations.
Overview
8
8
years of professional experience
8
8
years of post-secondary education
3
3
Languages
Work History
Engineer II, Process
Edwards Lifesciences
05.2024 - Current
- Qualify and validate manufacturing processes: Process Characterization, IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification).
- Optimize engineering processes by implementing innovative solutions and streamlining workflow with the use of engineering methods such as Six Sigma and Lean Manufacturing.
- Ensure compliance of the processes through Change Control.
- Ensure compliance of raw material along with the supplier quality team.
- Collaborate with a cross-functional team to solve compex manufacturing problems through non-conformances investigations and CAPAs.
- Give instructions and train technicians on executing qualifications and technical work.
Engineer I, Project
Edwards Lifesciences
07.2022 - 04.2024
- Coordinate manufacturing runs for design validations, microbiology tests and process qualifications; ensuring raw material required was in compliance with the company policy and personnel was available for the runs.
- Inventory management of raw material.
- Qualify and validate manufacturing processes: TFIQ (Tool & Fixture Installation Qualification), IQ (Installation Qualification) and PQ (Performance Qualification).
- Develop standard work instructions for the manufacturing processes.
- Give instructions and train technicians on executing qualifications and technical work.
Engineering Technician
Medtronic
10.2020 - 06.2022
- Qualify and validate processes as part of a process transfer project: TFIQ (Tool & Fixture Installation Qualification), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), Engineering Study for Parameters Confirmation.
- Translate visual aids and standard work instructions for transferred manufacturing processes.
- Drawing of fixtures and mechanical parts in SolidWorks.
- Opening and Closure of Change Control for transferred processes projects.
- Assisted in the development of enterprise risk management frameworks, supporting the integration of risk management across all organizational levels with the use of APQP Package.
Internship in Risk Assurance Services (RAS) Dpt.
PricewaterhouseCoopers
07.2016 - 08.2016
- Support to the Risk Assurance Services (RAS) team and attention to external clients.
Internship in Various Departments
PricewaterhouseCoopers
6 2015 - 08.2015
- Assistance and information to internal and external clients in Accounting and Finance department, Human Capital and the Reception Area.
Proyecto DMAIC - Control de Calidad
Instituto Tecnológico de Santo Domingo (INTEC)
05.2020 - 07.2020
- SPC (Statistical Process Control), Análisis de Causa Raíz, Implementación de mejoras
Education
Bachelor of Science - Industrial Engineering
Instituto Tecnológico De Santo Domingo (INTEC)
Santo Domingo, Dominican Republic 05.2017 - 05.2021
High School Diploma -
Educreatividad Maternal Pío Pío
Santo Domingo, Dominican Republic 05.2013 - 05.2017
Basics of Project Management - Project Management
International Business Management Institute
05.2001 -
Leadership And Team Development - Organizational Leadership
International Business Management Institute
05.2001 -
Statistical Process Control -
INFOTEP
05.2001 -
Systematic Ultrasonic Assembly -
HDI, Inc.
05.2001 -
Skills
Root Cause Analysis
Process Development and Qualification
Manufacturing Processes
Quality Assurance Controls
Project Management
Data Analysis
Technical Drawings
Effective Communication
Adaptability and Flexibility
Continuous Improvement
Team Collaboration
Software
MS Project
MS Office
SolidWorks
SAP
IBM Maximo
Timeline
Engineer II, Process
Edwards Lifesciences
05.2024 - Current
Engineer I, Project
Edwards Lifesciences
07.2022 - 04.2024
Engineering Technician
Medtronic
10.2020 - 06.2022
Proyecto DMAIC - Control de Calidad
Instituto Tecnológico de Santo Domingo (INTEC)
05.2020 - 07.2020
Bachelor of Science - Industrial Engineering
Instituto Tecnológico De Santo Domingo (INTEC)
05.2017 - 05.2021
Internship in Risk Assurance Services (RAS) Dpt.
PricewaterhouseCoopers
07.2016 - 08.2016
High School Diploma -
Educreatividad Maternal Pío Pío
05.2013 - 05.2017
Basics of Project Management - Project Management
International Business Management Institute
05.2001 -
Leadership And Team Development - Organizational Leadership
International Business Management Institute
05.2001 -
Statistical Process Control -
INFOTEP
05.2001 -
Systematic Ultrasonic Assembly -
HDI, Inc.
05.2001 -
Internship in Various Departments
PricewaterhouseCoopers
6 2015 - 08.2015
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