Alejandra Lopez Madrid
Tijuana,BC
Summary
- Professional engineer, with +5 years of hands-on experience in renowned medical device companies, and proficient in navigating medical standards and regulations, skilled in supplier quality management, expertise in quality control, process improvement, and supplier audits. Strong focus on team collaboration and achieving results. Reliable with flexible approach to meet changing needs. Known for analytical problem-solving and effective communication skills.
Overview
8
8
years of professional experience
Work History
Supplier Quality Engineer
Fisher & Paykel Healthcare Mexico, S.A. de C.V.
01.2021 - Current
- Managed relationships with key suppliers, fostering long-term partnerships that benefited both parties involved
- Managed non-conformances (CAPA/NCR/Complaints) and engineering changes, ensuring timely resolution and compliance with quality standards
- Monitored key performance indicators (KPIs) including Defects Per Million Samples (DPMS), Hold Orders (HO), Non-Conformance Reports (NCRs), and on-time disposition, implementing corrective actions as needed
- Collaborated with cross-functional teams to identify potential supply chain risks and develop contingency plans accordingly.
- Led audits for ISO 9001 and 13485 certifications of suppliers, ensuring adherence to quality management standards
- Managed the selection and approval of new suppliers, including component qualification through Supplier Part Approval Process (SPAP)
- Create procedures for raw material inspection
- Conducted comprehensive audits of suppliers'' facilities to ensure compliance with industry standards and regulations.
- Developed a robust supplier performance evaluation system, enabling continuous improvement initiatives across the supply base.
Vendor Quality Engineer – Electrical Parts
Foxconn Mexico S.A. de C.V.
01.2020 - 12.2020
- Strengthened vendor relationships by maintaining open communication and promptly addressing any concerns or issues.
- Supplier non-conformances following-up, including disposition
- IGQC coordination
- Managed engineering changes related to supplier components, ensuring seamless integration and compliance
- Developed and maintained the annual supplier quality audit agenda, ensuring alignment with organizational objectives
- Conducted supplier process validation to increase production lines and capacity for an aluminum-supplied component (Electrical)
Document Control Specialist
Foxconn Mexico S.A. de C.V.
05.2019 - 12.2019
- Document control management, document edition and release (Medical)
- Maintained version control for all documents, ensuring that only the most recent updates were in circulation at any given time.
- Performed document reproduction, printing documents from electronic sources such as email attachments, PDF files and cloud storage.
- Collaborated with cross-functional teams to maintain accurate, consistent, and high-quality documentation standards.
- Assisted with document troubleshooting and recovery of corrupt documents and files.
- Oversaw creation, routing and data input of bills of materials, ECOs, ECRs and ISO documents.
Training Intern
Posey S. de R.L. de C.V
04.2017 - 04.2019
- Lean manufacturing application, personnel trainings, training matrix, records maintenance
- Supported staff members in their daily tasks, reducing workload burden and allowing for increased focus on higher-priority assignments.
- Sorted and organized files, spreadsheets, and reports.
- Participated in workshops and presentations related to projects to gain knowledge.
- Prepared project presentations and reports to assist senior staff.
Education
Professional Degree - Development and Business Innovation Engineering
Universidad Tecnologica de Tijuana (UTT)
04.2019
Higher University Technician -
Universidad Tecnologica de Tijuana (UTT)
08.2017
QMS Lead Auditor Course - ISO 9001:2015 inclusive of ISO 13485:2016
Oriel Stat Matrix
12.2022
Internal Audit Certification - ISO 13485
Instituto Axis
12.2023
Certification in Dispatch of Synthetic Materials -
Technological University of Tijuana
12.2017
ILMEXUS” International Mobility Program - Building a CaliBaja Binational International Logistics Workforce
Southwestern Collage
12.2017
Skills
- Quality Management Systems
- ISO 13485
- ISO 9001
HARD SKILLS
- 21 CFR Part 820
- Minitab
- Teamwork and leadership
SOFT SKILLS
Personal Information
Age: 27
Training
- 2023, Internal Audit Certification ISO 13485, Instituto Axis
- 2022, QMS Lead Auditor Course (ISO 9001:2015) inclusive of ISO 13485:2016, Oriel Stat Matrix
- 2017, Certification in Dispatch of Synthetic Materials, Technological University of Tijuana, EI1576-ECE049-11
Timeline
Supplier Quality Engineer
Fisher & Paykel Healthcare Mexico, S.A. de C.V.
01.2021 - Current
Vendor Quality Engineer – Electrical Parts
Foxconn Mexico S.A. de C.V.
01.2020 - 12.2020
Document Control Specialist
Foxconn Mexico S.A. de C.V.
05.2019 - 12.2019
Training Intern
Posey S. de R.L. de C.V
04.2017 - 04.2019
Professional Degree - Development and Business Innovation Engineering
Universidad Tecnologica de Tijuana (UTT)
Higher University Technician -
Universidad Tecnologica de Tijuana (UTT)
QMS Lead Auditor Course - ISO 9001:2015 inclusive of ISO 13485:2016
Oriel Stat Matrix
Certification in Dispatch of Synthetic Materials -
Technological University of Tijuana
ILMEXUS” International Mobility Program - Building a CaliBaja Binational International Logistics Workforce
Southwestern Collage
Internal Audit Certification - ISO 13485
Instituto Axis