Vanessa Martinez

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

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

Graphology and Graphoscopy. Criminalistic area - Mexican College of Graphology and Criminalistic of Mexico City (2019-01 - 2021-12)

Diploma - Quality Engineer - CETYS University (2018-01 - 2019-12)

Master's degree - Master's of Science in Biochemistry and Molecular Biology - Universidad Autónoma de Baja California (UABC) (2012-01 - 2014-12)

Bachelor degree - Químico Farmacobiólogo - Universidad Autónoma de Baja California (UABC) (2006-01 - 2010-12)