Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Laura Elena Izquierdo Rodríguez

Reynosa

Summary

Experienced and certified Quality Assurance and Compliance Specialist with over 10 years of demonstrated success in automotive, medical device, plastics (molding & blow process), and logistics manufacturing environments. Proven track record in implementing, managing, and auditing Quality Management Systems (QMS) compliant with ISO 9001:2015, ISO 13485, ISO 14001, ISO 22716, ISO/TS 16949, VDA 6.3, HACCP, and CWF (B5.17). Adept at managing internal audits, coordinating external audits, and driving continuous improvement initiatives through the use of industry-standard tools and methodologies including APQP, FMEA, 8D, 5 Whys, Fishbone, Six Sigma, and GP12.

Highly skilled in CAPA management, regulatory compliance, and risk-based thinking, with deep expertise in interpreting engineering drawings, quality specifications, and product validation requirements. Successfully led cross-functional teams, supervised technical staff and quality auditors, and resolved complex internal and external customer complaints with strategic, cost-effective solutions. A reliable liaison between production, engineering, and quality departments, with excellent communication skills and a strong ability to train, coach, and develop quality personnel.

Experienced in managing quality performance metrics (e.g., PPM), facilitating management reviews, leading customer complaint investigations, developing audit schedules, maintaining documentation control systems, and supporting GMP compliance. Fluent in Microsoft Office, ERP platforms (JDE/SAP), and QMS tools, with a proactive approach to process improvement and compliance excellence.

Overview

1
1
Certification

Work History

QUALITY SUPERVIS/ INTERIN QUALITY MANAGER

4Front of Reynosa
  • Managed monthly Parts Per Million (PPM) reporting, achieving consistent quality compliance with an average PPM below target thresholds.
  • Led internal audits for ISO 9001, ISO 14001, ISO 45001, and CWF (B5.17); identified 20% reduction in non-conformities year-over-year.
  • Coordinated and facilitated annual ISO external audits, resulting in zero major non-conformities across 3 consecutive years.
  • Organized and chaired weekly IACAR and Corrective Action Review (CAR) meetings to resolve audit findings and customer claims effectively.
  • Conducted bi-monthly management reviews, ensuring timely alignment with procedural, regulatory, and operational changes.
  • Led the annual strategic audit review, updating PESTEL analyses to support risk mitigation and long-term planning.
  • Monitored and ensured closure of external audit findings, achieving 100% corrective action implementation within SLA timelines.
  • Supported budgeting process and led monthly budget reviews, controlling expenses and aligning with departmental KPIs.
  • Maintained and updated ISO documentation and controlled procedures, ensuring full compliance with audit and operational standards.
  • Developed and tracked Key Performance Indicators (KPIs) for quality assurance across production lines.
  • Facilitated JDE system (2005-3005) bi-weekly reviews on materials on hold; coordinated final disposition decisions with Purchasing.
  • Requested and coordinated external training programs for internal and QA auditors, increasing competency and cross-skill coverage by 30%.
  • Reviewed and approved overtime, leave, and time-off requests using the TRESS system, maintaining optimal staffing levels.
  • Conducted weekly Corrective Action (CA) reviews to address systemic recurrence, internal issues, and 3rd-party audit actions.
  • Led Business Evaluation Meetings, documenting decisions and updating improvement action trackers for leadership reporting.
  • Provided comprehensive support to ISO Team Leaders, preparing data-driven audit reports and compliance dashboards.
  • Designed, implemented, and maintained a document control system for ISO standards, training materials, and process documentation.
  • Ensured ongoing compliance with ISO 9001:2015 and HACCP by acting as the designated ISO Management Representative.
  • Drafted audit schedules and delegated responsibilities to internal teams, ensuring audit readiness and process ownership.

ISO Coordinator - Quality

Albea
  • Acted as ISO Management Representative, ensuring full organizational compliance with ISO 9001:2015 and HACCP requirements.
  • Coordinated the performance reporting of the QMS to top management, aligning outcomes with business goals and strategic planning.
  • Led and scheduled internal audits for ISO 9001:2015; ensured timely closure of findings and presented audit outcomes in Management Review Meetings.
  • Maintained and controlled all ISO-required documentation, supporting system consistency and audit readiness.
  • Coached department managers and process owners on ISO 9001:2015 documented processes and compliance expectations.
  • Reviewed and evaluated Corrective and Preventive Action (CAPA) reports, ensuring proper root cause identification and closure within compliance timelines.
  • Maintained a CAPA tracking system to monitor audit non-conformities, improvement actions, and major/minor findings based on MS-SGC (Management System – Strategic Governance Criteria).
  • Supported cross-functional teams by linking documentation, eliminating duplication, and improving system efficiency across all departments.
  • Assisted in the development of ISO 9001:2015 and EN-15593 compliant systems, ensuring clear roles, responsibilities, and documentation hierarchy.
  • Developed and delivered training programs for internal auditors and document/process owners, enhancing internal audit readiness and system ownership.
  • Designed and managed the ISO audit schedule, assigning responsibilities and overseeing execution to ensure compliance and audit scope coverage.
  • Conducted nonconformance analysis and led root cause investigation sessions, generating practical, cost-effective corrective actions.
  • Participated in and documented Business Evaluation Meetings, aligning quality metrics with management priorities and system effectiveness.
  • Authored and reviewed audit reports, identifying product or process areas of compliance and deficiency, contributing to a 20% increase in audit readiness and reduction in repeat issues.
  • Demonstrated ability to work independently or collaboratively, meet tight deadlines, and communicate complex findings clearly to cross-functional stakeholders.

Sr. Quality Engineer – Inflators (Safety Bags)

Automotive Research company (ARC)
  • Over 7 years of experience in automotive and logistics environments with a focus on quality assurance, compliance, and systems improvement.
  • Strong practical knowledge and application of Core Quality Tools: APQP, FMEA, Control Plans, and MSA, supporting both new product launches and continuous improvement efforts.
  • Proficient in ISO 9001, ISO 14001, and ISO/TS 16949 standards, ensuring robust Quality Management Systems across the value chain.
  • Led a team of 18 Quality Auditors, managing performance, workload distribution, and audit planning, resulting in improved coverage and reduced rework by 20%.
  • Conducted failure investigations of field returns; analyzed root causes and implemented stop-ship/stop-production decisions as needed to protect customers and brand integrity.
  • Proactively resolved internal and external customer quality issues, communicating “Lessons Learned” and Validation Terms to reduce issue recurrence.
  • Developed and executed cost-effective corrective actions that minimized quality issues while protecting production flow and customer satisfaction.
  • Participated in Advanced Product Quality Planning (APQP) reviews, driving procedural revisions to enhance process robustness and product conformity.
  • Monitored GP12 inspections and implemented new quality strategies, resulting in increased first-pass yield and improved customer feedback.
  • Supervised and coached technical staff in quality standards, document control, and VDA 6.3 audit requirements, strengthening audit readiness.
  • Managed and maintained Poka-Yoke systems and Golden Sample documentation, ensuring reliability in error-proofing during live production.
  • Created and maintained quality documentation to ensure process alignment, traceability, and regulatory compliance.
  • Collaborated cross-functionally with Production, Engineering, and Customer Service to align quality expectations and provide timely corrective action updates.
  • Oversaw and followed up on Corrective and Preventive Actions (CAPAs) related to internal audits and external (customer/supplier) findings.
  • Actively tracked engineering changes and system performance in final project stages, escalating risks and recommending mitigation strategies.
  • Attended regular project team meetings, providing updates on progress, quality risks, and compliance metrics.

Sr. Quality Engineer – Molding Area

Plastic Manufacturing – Molding & Blow Process
Technimark, Reynosa.
  • Led and mentored a team of Quality Inspectors, providing daily coaching and training to identify, analyze, and resolve product quality issues, resulting in a measurable reduction in customer complaints.
  • Ensured full compliance with ISO 9001, ISO 22716, HACCP, and Good Manufacturing Practices (GMP) by enforcing internal procedures and conducting internal audits (45 hours of verified audit activity).
  • Supervised quality assurance processes for incoming raw materials and molded plastic components, improving first-pass yield by streamlining inspection protocols and supplier communication.
  • Collaborated with engineering and production teams to investigate non-conformances, implement corrective actions, and monitor effectiveness through data-driven reviews.
  • Served as the primary customer interface for dimensional requirements, measurement results, and approvals, ensuring product conformity to specifications and maintaining customer satisfaction.
  • Supported document control and audit readiness by maintaining up-to-date inspection records, work instructions, and compliance documentation.
  • Monitored the implementation of preventive actions on recurring issues, using root cause analysis tools such as 5 Whys, Fishbone (Ishikawa), and Pareto analysis.
  • Participated in internal quality audits for ISO and HACCP standards and supported site-wide quality improvement initiatives based on audit findings.
  • Worked cross-functionally to align inspection results with customer-specific requirements, driving process improvements that increased on-time delivery and product compliance rates.
  • Ensured that all operations within the molding area adhered to government regulations, GMP policy, and company-specific standard operating procedures (SOPs).

Education

Master’s Degree - Quality Total

SLP University
San Luis Potosí, México
01.2004

Chemical Engineer -

Reynosa, Tamaulipas, Mexico
01.1993

Skills

  • CAPA Management: Proficient in managing Corrective and Preventive Actions (CAPA) with both customers and suppliers, ensuring timely closure and regulatory compliance
  • Quality Standards Expertise: Strong working knowledge of ISO 13485, ISO 9001, GMP regulations, and all national and international quality standards as outlined in the Quality Manual
  • Problem Solving & Root Cause Analysis: Skilled in applying 8D, 5 Whys, Fishbone/Ishikawa diagrams, and Six Sigma methodologies for structured problem-solving and continuous improvement
  • Continuous Improvement: Hands-on experience implementing Lean Manufacturing and Continuous Improvement models to reduce waste and improve quality performance
  • Engineering Interpretation: Proficient in reading and interpreting technical drawings, specifications, BOMs, change orders, and engineering documentation
  • Standards Interpretation: Adept at understanding and applying standards and regulatory requirements for medical devices (ISO 13485/GMP) and automotive (ISO/TS 16949, VDA 63) industries
  • Microsoft Office Suite: Advanced user of Excel, Word, PowerPoint, and Outlook for data analysis, reporting, training materials, and quality documentation
  • Audit & Compliance: Knowledge of internal and external audit preparation, quality manual management, and document control aligned with international standards

Certification

Lead Auditor Certifications:

  • Lead Auditor – ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018
  • Lead Auditor – IATF 16949:2016

Internal Auditor Certifications:

  • Internal Auditor – CWF B5.17
  • Internal Auditor – ISO 13485:2016 (Medical Devices)
  • Internal Auditor – HACCP (Hazard Analysis & Critical Control Points)

Quality & Process Improvement:

  • Certified Six Sigma Green Belt
  • Risk Management Training – Focused on enterprise and operational risk strategies
  • ISO 14091:2021 – Adaptation to climate change through risk-based approaches
  • Environmental Legislation – Awareness and compliance with local and international environmental laws

Nondestructive Testing (NDT):

  • Liquid Penetrant Testing – Level I & II
  • Visual Inspection – Level I & II

Timeline

QUALITY SUPERVIS/ INTERIN QUALITY MANAGER

4Front of Reynosa

ISO Coordinator - Quality

Albea

Sr. Quality Engineer – Inflators (Safety Bags)

Automotive Research company (ARC)

Sr. Quality Engineer – Molding Area

Plastic Manufacturing – Molding & Blow Process

Master’s Degree - Quality Total

SLP University

Chemical Engineer -

Similar Profiles

CREATE PROFILE
Laura Elena Izquierdo Rodríguez