FLOR DE DALIA CERVANTES
Tijuana
Summary
Quality Management Systems professional with broad experience across medical device, electronics, telecommunications, and automotive manufacturing. Led first-time ISO 9001:2015 and IATF 16949 certification, built controlled document and training systems, and supported audit readiness, CAPA, and management review activities in multi-site manufacturing environments.
Overview
1
1
Certification
31
31
years of professional experience
Work History
Quality Management System Coordinator
WHOOP
04.2022 - Current
- Spearheaded implementation and successful certification of the organization's first ISO 9001:2015 QMS.
- Achieved certification through ABS Quality Evaluations.
- Contributed significantly to SMETA accreditation.
- Coordinated 20 internal audits annually, ensuring compliance and continuous improvement of quality management systems.
- Established and trained two internal auditor teams, enhancing audit capabilities with 30 certified auditors.
- Developed and implemented more than 150 controlled documents.
- Designed and implemented the Competency Management System supporting annual training compliance for approximately 85% of the workforce.
- Managed Training and Document Control functions supervising 8 team members.
- Prepared and facilitated management review meetings, driving strategic discussions through comprehensive KPI reporting.
- Systems: Smartsheet, TeamGuru, NetSuite, Arena PLM, Power BI, Jira, SharePoint, Zoho Forms, DocuSign, BoxSign.
Quality Management Systems Coordinator / Document Control Coordinator
VOLEX DE MÉXICO
01.2012 - 01.2022
- Project Leader for implementation and successful certification of the organization's first IATF 16949 Quality Management System.
- Achieved certification readiness in eight months, ensuring compliance with IATF 16949 standards.
- Coordinated integrated audit programs for ISO 9001, ISO 13485, IATF 16949, and ISO 14001, enhancing overall quality assurance framework.
- Supported compliance with ISO 9001, ISO 13485, IATF 16949, ISO 14001 and MEDACRED.
- Supported implementation of customer-specific requirements and FDA 21 CFR Part 820 expectations.
- Managed approximately 400 controlled documents.
- Executed implementation of Eversign, APQP, PPAP, and change control system to streamline document management processes.
- Supervised 1 Document Control Supervisor and 5 Document Control Specialists.
Multiple Progressive Roles
MEDIMEXICO
01.1996 - 01.2012
- Coordinated document control processes, enhancing workflow efficiency.
- Managed company-wide document control systems, ensuring compliance and accessibility.
- Internal Auditor supporting ISO 13485 and ISO 9001.
- Coordinated sterilization and product release activities, ensuring timely delivery of products.
- Supervised 5 Quality Inspectors.
- Supervised 8 Production Supervisors in a 2,500-employee operation.
Education
Administration Technician -
College of Bachelors of the State of Sinaloa
01-1996
Skills
- Regulatory compliance (ISO 9001, ISO 13485, IATF 16949, ISO 14001, SMETA, FDA 21 CFR Part 820)
- Quality management systems
- Internal auditing
- Document Control Management
- Risk Management
- CAPA management
- Change control
- Training coordination
- Management review
- Attention to detail
- Cross functional communication
- Problem solving
- Process improvement
- Team leadership
- Multitasking and organization
Certification
Lead Auditor – ISO 9001, Lead Auditor – ISO 13485, Lead Auditor – IATF 16949, Internal Auditor – ISO 14001, Core Tools, VDA 6.3 Audits, CAPA, Corrective Actions, Competency Management, FDA 21 CFR Part 820
LANGUAGES
Spanish – Native, English – Professional Working Proficiency (Reading & Writing), Conversational Proficiency
Accomplishments
- Led implementation and successful certification of the first ISO 9001:2015 Quality Management System for a 1,000-employee manufacturing organization.
- Achieved ISO 9001:2015 certification during the first certification audit with only four minor nonconformities.
- Successfully led implementation and certification of the organization's first IATF 16949 Quality Management System.
- Developed and trained 30 Internal Auditors.
- Designed and implemented enterprise-wide systems for Audit Management, Competency Management, CAPA, Risk Management, Change Control and Document Control.
- Managed Quality System compliance activities across organizations ranging from 1,000 to 2,500 employees.
Timeline
Quality Management System Coordinator
WHOOP
04.2022 - Current
Quality Management Systems Coordinator / Document Control Coordinator
VOLEX DE MÉXICO
01.2012 - 01.2022
Multiple Progressive Roles
MEDIMEXICO
01.1996 - 01.2012
Administration Technician -
College of Bachelors of the State of Sinaloa