Carla Hernandez
Dubai
Summary
Industrial Engineer with hands-on experience in process transfers, project management, and continuous improvement initiatives. Known for a strong sense of responsibility, efficiency, and effective communication. Committed to delivering high-quality results and contributing to the growth and success of the organization through strategic problem-solving and cross-functional collaboration.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Transfer Engineer
Johnson & Johnson Medical Devices
Tijuana
11.2023 - 04.2025
- Represented Johnson & Johnson at Foxconn during the process transfer from Ciudad Juarez.
- Supported the transfer of a medical device product, classified as Class II and Class III, ensuring compliance with regulatory and quality requirements.
- Coordinated technical implementation and process validation at the manufacturing site.
- Prepared and presented detailed progress reports, documenting the status of the transfer, executed activities, and identified improvement opportunities.
- Analyzed and reviewed critical process documentation (PIs, MOPs, IQs, TMVs, MVPs), identifying and managing necessary adjustments to ensure compliance with product specifications and validation requirements.
- Collaborated in preparing and reviewing regulatory documentation for product approval and registration.
Project Quality Engineer
Lean Lead Consulting
Tijuana
07.2022 - 08.2023
- Analysis on design output under FDA regulations.
- Transfer from Design into manufacturing aligned with ISO & FDA.
- Analysis and testing of design outputs through different vendors (Packaging Test, Design Label Verification, Drop Test, etc.)
- Direct supervision on engineering changes to ensure proper implementation.
- Ensure traceability of all risk controls to the design, specifications, and verification/validation processes.
Integration Engineer
Fisher & Paykel Healthcare
Tijuana
09.2020 - 07.2022
- Actively involved in project transferring from New Zealand to México.
- Person in charge of development trustworthy and validated processes for the manufacturing team.
- Full comprehension of eDrawing and specifications.
- Medium-High complexity process development and equipment validation (IQ, OQ, PQ).
- Creation of process validation documents such as SOP, MF, TM, PTX and FMA.
- BOM Creation, routings and change implementation.
Education
B.A. - Industrial Engineer
Instituto Tecnologico de Tijuana
Tijuana, BC, México01.2021
Skills
- Lean manufacturing
- Six Sigma
- Process validation
- Document control
- Regulatory compliance
- Quality assurance
- Effective communication
- Team collaboration
- FDA regulations
- Attention to detail
Certification
Certificate in Solid Works, 2013
Languages
English
Upper Intermediate (B2)
B2
Spanish
Native
Native
Timeline
Transfer Engineer
Johnson & Johnson Medical Devices
11.2023 - 04.2025
Project Quality Engineer
Lean Lead Consulting
07.2022 - 08.2023
Integration Engineer
Fisher & Paykel Healthcare
09.2020 - 07.2022
B.A. - Industrial Engineer
Instituto Tecnologico de Tijuana