Adriana García Gallardo
Ciudad Juárez,CHH
Summary
Biomedical engineer with solid background in quality assurance in medical devices industry, expertise in problem-solving and cross-functional collaboration.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Senior Quality Engineer
Biosense Webster (J&J)
Juarez, Mexico
01.2024 - Current
- Support during stabilization of New products.
- Collaboration during internal/external audits.
- People leader
- Facilitated change request and notification processes within Windchill system.
- Support in improvement projects.
- Led cross-functional collaboration during NCRs investigations , overseeing investigation actions and product disposition to ensure comprehensive closure of NCRs.
- Directed customer complaint investigations to ensure timely resolution.
- Analyzed production processes through audits to pinpoint opportunities for optimization and quality enhancement.
- Guided and supported individuals through mentorship to cultivate skills and promote talent development.
Quality Engineer II
Biosense Webster (J&J)
02.2022 - Current
- Facilitated collaboration on NCRs, overseeing investigation actions and product disposition until resolution.
- Support in Effectiveness monitoring actions of CAPAs.
- Support in Customer complaints.
- Analyzed and responded to business demands, focusing on legacy product maintenance and new product introduction.
Process engineer
BD Bard (Davol surgical innovations)
08.2021 - 02.2022
- PFMEA´s update project (Alignment of local procedures with requirements of corporative procedures, determination of failure modes by production line at the building, assignment of severity according to the product impact in patients, determination of risk level and determine containment actions if a failure mode is in high level).
Quality Technician
BD Bard (Davol surgical innovations)
12.2019 - 08.2021
- Executed updates to documentation, including procedures, forms, BOMs, and instructions.
- Monitored and supported corrective and preventive actions for audit findings related to MRRs. Assisted in implementing savings projects to enhance operational efficiency. Collaborated with teams to address non-conformance material report actions.
- Executed participation in external and internal audits, ensuring compliance with established protocols.
- Conducted audits for 5S initiatives and led continuous improvement projects.
- Facilitated collaboration on improvement initiatives and cost-saving projects.
- Facilitated collaboration and execution of engineering studies and testing methodologies.
Quality Intern
BD Bard (Davol surgical innovations)
07.2019 - 12.2019
- Collaboration in the process validation execution.
- Assistance in document control
- Assistance for monthly and weekly metric reports (complaints and MRRs)
- Inventory control
- Assistance for following to DHR and Non-conformance records
Assistant
Laboratorio de Electrónica Flexible
01.2014 - 01.2019
- Contributed to research and development in inorganic semiconductors and nanoparticles.
- Research on thin films by CuS with variation of parameters and doped with different Nps for a future application as a transducer for their application in a glucose biosensor.
- Management of chemical substances in different process.
- Inventory control of laboratory.
- Training of new members of the laboratory applications and techniques.
- Basic management of material characterization equipment: Uv-Visible, 4W, FTIR and skills in laboratory activities in the development of research projects.
- Executed development of comprehensive research and chemical reports.
- Led a team in conducting thorough investigation processes.
Education
Biomedical Engineer -
Universidad Autónoma de Ciudad Juárez
09.2020
Skills
- Collaborative work
- Responsible
- Innovative thinking
- Initiative-driven
- Attention to detail
- Quality processes
- Non-conformance processes
Extra-academic activities
2020 Preparation of isolation capsules for transfer of patients with COVID 19 as a member of BM 9. Capsules was donated to Cruz Roja Mexicana, IMSS and URGE at Cd. Juárez, Cd. Ahumada and Casas Grandes, Chihuahua. 2019 1st place in Engineering and Industry category in oral presentation at “6to Encuentro de Jóvenes Investigadores del estado de Chihuahua”, with the Project “Optimización de un transductor de película delgada de CuS para su potencial de aplicación en un biosensor de glucosa”
Certification
- Training in JJRC Compliance Academy, focusing on auditing management certification.
- Orange Belt certification
Languages
Spanish: Native language
English: Intermediate
Timeline
Senior Quality Engineer
Biosense Webster (J&J)
01.2024 - Current
Quality Engineer II
Biosense Webster (J&J)
02.2022 - Current
Process engineer
BD Bard (Davol surgical innovations)
08.2021 - 02.2022
Quality Technician
BD Bard (Davol surgical innovations)
12.2019 - 08.2021
Quality Intern
BD Bard (Davol surgical innovations)
07.2019 - 12.2019
Assistant
Laboratorio de Electrónica Flexible
01.2014 - 01.2019
Biomedical Engineer -
Universidad Autónoma de Ciudad Juárez
Qualifications
- Use of software:
- ETQ, JDE, Windchill, MES, Master Control, windows system, office package (Word, excel, Power Point, Project, Outlook).