Eduardo Fabricio Arzate Vázquez
Industrial Engineer
Juarez
Summary
Professional with extensive experience in the medical device sector and pharmaceutical industry, capable of assuming responsibilities and making sound decisions. Extensive experience in work environments where commitment and the ability to work as part of a team are valued. Characterized by been dynamic, proactive, and a leader.
Overview
7
7
years of professional experience
9
9
years of post-secondary education
Work History
Complaint Analyst
Johnson & Johnson, Medical Devices
7 2023 - Current
- Responsible for complaint management
- Establish reports for the prompt review of new complaints, regulatory reporting decisions, and follow-up
- Develop, establish, prepare, and distribute dashboards and reports to assure complaints are processed in a timely manner
- Responsible for coding the event and ensuring that all the required information for a complaint file is obtained and properly documented to make a final regulatory reporting decision
- Evaluates all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering
- Responsible for tracking, receiving, and shipping products as needed
- Execute the complaints analysis and failure investigations daily and document the analysis results and relevant information to the Med Watch reports in the assigned product families
- Approve the complaints in the assigned product families
- Set up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service, and Technical Services
- Investigate and develop solutions related to procedures and process issues
- Participate in Quality improvement processes and projects
- Provide support in product transfer and new product development as needed
- Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA.
Supervisor de Operaciones de Calidad
Laboratorios P
2020.03 - 2023.06
- Management of tools for root cause analysis of failures and implementation of improvement actions.
- Execution of maintenance programs for the equipment for inspection of products in process.
- Management of projects involved with operating the plant and its products through the Change Control system.
Member of the committee for developing new products, technology transfers, and changes in raw material supplies.
Management of indicators (KPIs) for performance evaluation. - Responsible for the review of protocols, validation reports, test protocols, and URS.
- Administration of the quality management system (deviations, nonconformance, complaints, change controls, risk management, and CAPAs) of the area under charge.
- Management of documents for compliance with regulatory requirements.
- Coordinate periodic reviews of manufacturing master records.
- Coordinate the inspection of packaging materials and supplies used in manufacturing processes.
- Responsible for preparing accident investigation reports and establishing controls to prevent their recurrence.
- Coordination of the integration process and on-the-job training of personnel.
- Personal Management.
Ingeniero De Calidad
Laboratorios PiSA S.A. de C.V.
2018.01 - 2020.03
- Verify that the activities related to the manufacturing, packaging, analysis, validation, and storage of products are carried out according to what is described in the master documents involved in the management of the Quality System.
- Provide leadership and supervision of all areas in terms of quality assurance.
- Generation of quality reports.
- Handling visits and audits of clients and regulatory entities.
- Responsible for immediate response to quality requirements for clients, regulatory support, and complaints.
- Responsible for the control and monitoring of non-conformities, as well as the implementation of corrective actions for the same reports.
Education
Bachelor's - Industrial Engineering
Universidad Del Valle De México (UVM)
2018.01 - 2021.05
Bachelor's Chemical Engineering -
Universidad Nacional Autónoma De México (UNAM)
2011.01 - 2016.05
Skills
Implementation and management of quality systems for compliance with regulatory requirements.
Knowledge of good manufacturing practices and good laboratory practices.
Certification as Internal Auditor ISO 13485:2026 and ISO 19011:2018
Carrying out internal, external, and regulatory audits.
Handling tools for root cause identification.
Handling applications such as SAP NetWeaver, Trackwise, JDEdwards, and ECM.
Handling Microsoft Office packages.
Personnel Management
Leadership skills
Team oriented
Adaptability
Organizational skills
Multitasking skills
Problem solving
Languages
Inglés
Intermediate (B1)
Timeline
Supervisor de Operaciones de Calidad
Laboratorios P
2020.03 - 2023.06
Bachelor's - Industrial Engineering
Universidad Del Valle De México (UVM)
2018.01 - 2021.05
Ingeniero De Calidad
Laboratorios PiSA S.A. de C.V.
2018.01 - 2020.03
Bachelor's Chemical Engineering -
Universidad Nacional Autónoma De México (UNAM)
2011.01 - 2016.05
Complaint Analyst
Johnson & Johnson, Medical Devices
7 2023 - Current
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