Quality Management System and Regulatory Affairs Engineer II - Jabil Healthcare
(2024-01 - 2025-12)
- Support in external an internal audit
- Support and coordinate BBQ program (Behavior Based Quality) implementation and monitoring of the project
- Provide regulatory training to plant personnel in areas such as: ISO13485 / FDA / JPAL / COFEPRIS and applicable regulations based on company growth
- Support and coordinate Gemba walks, prepare monthly Gemba walk calendar to managers
- Support in verification of effectiveness of CAPAs
Compliance Engineer - Jabil Healthcare
(2023-01 - 2024-12)
- Support in external an internal audits
- Support site audit readiness activities to ensure inspection at all time
- Participate in audit preparation activities (auditor logistics, front room/back room arrangements, identifying /preparing SME's etc)
- As required, assess the risk and applicability of audit observations from other Jabil sites to determine impact to the site
- Support mock inspections as part of External Inspection Readiness activities
- Ensure adequate corrective actions for internal audits
- Drive compliance improvements, which results from audits, Gemba walks and other system indicators
Quality Assurance and Regulatory Affairs Lead (QA/RA Lead) - Providien, A Carlisle Company
(2019-01 - 2022-12)
- Manage and Coordinate Internal and External Audits to be in compliance with National and International regulation
- Responsible for Technical Files, Product listing and Device Master Records
- Develop and Maintain the Quality Management System according ISO 13485:2016 and FDA QSR Title 21 part 820
- Approve Change Orders to support regulatory compliance and global regulations
- Coordinate and Support Product transfer from Customer to Tijuana site for new product regulatory plan
- Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations
- Manage and support plant Document Control staff
Quality Engineer - Providien, A Carlisle Company
(2018-01 - 2019-12)
- Identify and analyze problems regarding to the Quality of a product
- Follow-up to procedures of the Quality System according to ISO 13485: 2016
- Management of the form NCMR (Non Conformance Material Report)
- Analysis and investigation to report actions in Customer Complaints and CAPAs
- Presentation of weekly indicators (Scorecard)
Clinical Lab Specialist - Nypro Healthcare Baja, (Jabil )
(2017-01 - 2018-12)
- Support in Primary & Release Test in Clinical Analyzers VITROS 5600 and VITROS 5,1
- Support in keep perform indicators
- Support in CAPAs, NCMRs and Complaints
Clinical Lab Technician - Nypro Healthcare Baja, (Jabil )
(2017-01 - 2017-12)
- Support in cleaning, validation in clinical analyzers VITROS 5600 and VITROS 5,1 in refurbished area
- Support in quality alerts and keep perform indicators
Clinical Analyst - Certus Clinical Laboratory
(2015-01 - 2016-12)
Departament of Microbiology
- Sowing of biological samples
- Staining
- Blood chemistry
- Handling of microscan equipment and Vitek2 Compact
Clinical Analyst - Salud Digna Clinical Laboratory
(2011-01 - 2012-12)
- Phlebotomist
- Serology
- Uroanalysis
