Fatima Danae Danae Reyes Romero
Tijuana
Summary
Dedicated Quality Engineer with experience in the medical industry, specializing in quality assurance and continuous improvement. Proficient in utilizing quality tools and methodologies, including Six Sigma, FMEA, and root cause analysis, to identify and resolve quality issues. Demonstrated ability to enhance product reliability and compliance with regulatory standards, while collaborating cross-functionally to implement effective quality control processes. Committed to driving operational excellence and fostering a culture of quality within organizations.
Overview
5
5
years of professional experience
Work History
Production Quality Engineer
ACON Labs
Tijuana, BC
06.2023 - Current
- Non Conforming material system management, generation, support with risk analysis, MRB meetings and evidence administration.
- Change control system management, documentation administration, meeting control and support with CORs content.
- Experience in ISO 13485, COFEPRIS and MDSAP audits as host and auditee of the quality system.
- Experience in managing quality inspectors, administration of their activities and training.
- Validation system management, validation number generation, responsible for MVP update, validation review support (IQ, OQ, and PQ) for manufacturing processes, TMVs, facilities, and excel spreadsheets.
- Experience in customer complaint resolution, containment, initial response, investigation, root cause analysis, effectiveness, communication, and follow-up meetings.
- Experience in corrective action response (CAPAS). Follow-up of quality events in the production process, improvement of inspection times in processes, creation of documentation for product inspections.
Supplier Quality Engineer ll
Medtronic
Tijuana, BC
11.2022 - 04.2023
- Management of suppliers (services) from two locations in the United States.Direct communication with the supplier, requisition of services according to internal requests, communication for complaints, procurement of new services and liaison between the engineering department and supplier.
- Implementation of remediation projects for suppliers in Medtronic global sites, follow up with SQE's of the sites to work on, and creation of documentation for remediation changes.
- Processing of internal changes and processing of requirement changes by the supplier.
Quality Engineer
ACON Labs
Tijuana, BC
03.2022 - 11.2022
- Suppliers’ management and SCAR generation, evaluation, approval and contact with suppliers
- Rework experience,quality controls, and DHRs for rework requirements.
- Perform internal audits in audit manufacturing processes and quality system.
- Experience in ISO 13485 audits, participation as an auditee in the quality management system.
- Quality in process for manufacturing areas, generation of in-process quality documentation and SOPs.
- Experience in QA auditors’ management and training
- Customer complaints resolution.
- Managements and generation for NCMR’s, CAPA’s and COR’s
QA Technical Support Specialist
ACON Labs
Tijuana, BC
04.2021 - 03.2022
- Generation, management, and monitoring of CAPAs.
- Management, control and generation of NCMR’s, evaluation of status for nonconformance material conducting MRB meetings
- COR process management, assignment of COR control number, review of form content, and review of change through meetings.
- Generator of lots of numbers for manufacturing process, verification of traceability of DHRs, batch record review, administration of DHRs, and release of batches through Quality review and approval.
- Technical Support specialist for United States customers in medical products.
Jr Quality Engineer
VelcroMex Company
Agua Prieta, Son
05.2020 - 04.2021
- Customer complaints, initial response, root cause analysis, containment actions, coordinate meetings for 8D, corrective action monitoring, creation of quality alerts, visual aids, work instructions, and procedures.
- Incoming inspection, SCARS generation, supplier communication, Incoming Control Plan elaboration, material review, and release.
- Internal audits participation and control plans generation.
- Discrepancy Reports elaboration (NCs).
Document Control Analyst
VelcroMex Company
Agua Prieta, Son
10.2019 - 05.2020
- Process documentation review, approval, and distribution.
- Scanning and correction of DHR, coordination of engineering changes, verification and receipt of Device Master Record, archiving master samples.
- Manage of database for documentation and records retention.
Education
Degree in Biomedical Engineering - Specialty in Bionics
Technological Institute of Hermosillo
12-2018
Skills
- Root Cause Analysis
- Critical Thinking
- Failure Investigation and Analysis
- Risk Management
- Process control documentation
- Quality processes
- SOP Development
- Microsoft Office (advanced)
- Solidworks (beginner)
- Minitab (beginner)
- Autocad (beginner)
- Responsible
- Teamwork
- Proactive
- Organized
- Determined
Languages
Spanish
First Language
English
Advanced (C1)
C1
Timeline
Production Quality Engineer
ACON Labs
06.2023 - Current
Supplier Quality Engineer ll
Medtronic
11.2022 - 04.2023
Quality Engineer
ACON Labs
03.2022 - 11.2022
QA Technical Support Specialist
ACON Labs
04.2021 - 03.2022
Jr Quality Engineer
VelcroMex Company
05.2020 - 04.2021
Document Control Analyst
VelcroMex Company
10.2019 - 05.2020
Degree in Biomedical Engineering - Specialty in Bionics
Technological Institute of Hermosillo
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