Florencia Medina
Funes
Summary
More than 14 years of experience in Quality areas for manufacturing industries. Customer interface. Team management. Problem solving and risk management expert.
Overview
14
14
years of professional experience
Work History
Quality Engineering Manager
TERRAGENE (Biotechnology)
01.2024 - Current
- Ensure all manufacturing Process are validated as ISO 13485 requires (IQ, OQ, PQ).
- Lead PQ process and report results to the company stakeholders.
- Lead process validation strategies.
- Responsible for Processes efficiency analysis and implementation of improvements.
- Define and Implement Continuous improvement methodology in the company. Train stakeholders.
- Lead all Problem Solving analysis within the company.
Project Quality Manager for South America
PLASTIC OMNIUM (Automotive)
02.2020 - 12.2023
- Assure the development & plant teams deliver customer satisfaction for a specific customer. Regional responsibility to ensure the knowledge is transferred and understood. Be the voice of the customer.
- Quality risk management & customer management in programs, launch and serial life.
- Responsible for Project Quality Leaders team.
- Regional Leader in Problem Solving management (8D)
- Responsible for regional programs PPAP
- Achievement: Successful internal/external audits, project launches and acquisition management for new customer business.
Project Quality Leader/Geometry Engineer
PLASTIC OMNIUM (Automotive)
01.2015 - 01.2020
- Ensure that customer quality requirements are met and PPAP to customer is submitted. Monitor Quality Project status and escalate risks in project. Support the plant and project organization to improve the process to secure launch and ramp-up. Geometry, aspect & validation assessment. PFMEA. Control Plan.
- As a Geometry Engineer: Manage Design/Development/Validation of Checking Fixtures.
- Achievement: Successful launches for several OEM without customer claims.
Lean Specialist/ Quality Assurance Leader
CEVA LOGISTICS (Automotive)
07.2013 - 07.2014
- Leader in implementation and maintenance of Quality System and Lean Manufacturing in General Motors site. PFMEA/KAIZEN/5S/8D management.
- Achievement: Successful internal/external audits. Processes optimization.
Quality Assurance Coordinator
CALSA (Food Industry)
11.2011 - 06.2013
- Leader in implementation and maintenance of Quality - Food Safety Systems
- Achievement: Successful internal/external audits. Processes optimization.
Education
Six Sigma – Green Belt - undefined
Universidad Austral
Bs As01.2021
Industrial Engineer -
Universidad de Buenos Aires (UBA)
Bs As01.2013
Skills
- ISO 9001:2015
- IATF 16949:2016
- ISO 13485:2016
- Medical Device Software Validation
- ISO 9001 Internal Auditor
- IATF 16949 Internal Auditor
- VDA 63 / 65
- Kaizen/5S/8D/A3
- GD&T/MSA/CEP
- APQP – PPAP
- DFMEA/PFMEA/Control Plan
LANGUAGES
Spanish
Bilingual or Proficient (C2)
English
Advanced (C1)
Portuguese
Upper intermediate (B2)
Timeline
Quality Engineering Manager
TERRAGENE (Biotechnology)
01.2024 - Current
Project Quality Manager for South America
PLASTIC OMNIUM (Automotive)
02.2020 - 12.2023
Project Quality Leader/Geometry Engineer
PLASTIC OMNIUM (Automotive)
01.2015 - 01.2020
Lean Specialist/ Quality Assurance Leader
CEVA LOGISTICS (Automotive)
07.2013 - 07.2014
Quality Assurance Coordinator
CALSA (Food Industry)
11.2011 - 06.2013
Six Sigma – Green Belt - undefined
Universidad Austral
Industrial Engineer -
Universidad de Buenos Aires (UBA)