Summary
Overview
Work History
Education
Skills
LANGUAGES
Timeline
Generic
Florencia Medina

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 As
01.2021

Industrial Engineer -

Universidad de Buenos Aires (UBA)
Bs As
01.2013

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)

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Florencia Medina