Paulette Malacara

Sr. Manager, Quality Management System (EMI) at BD

Role
Sr, Manager Quality Management System, Emi at BD
Location
Irvine, CA, US
LinkedIn followers
500 followers

About Paulette Malacara

Experienced Compliance Manager with a demonstrated history of working in the medical device industry. Skilled in DMAIC, Medical Devices, Failure Mode and Effects Analysis (FMEA), Validation, and Six Sigma. Strong legal professional graduated from Universidad Autónoma de Ciudad Juárez.

Experience

  1. Sr, Manager Quality Management System, Emi

    BD

    Aug 2025 — Present · US

Education

  • Universidad Autónoma de Ciudad Juárez

    B.S. Mechatronic and Robotics Engineer

    2006 — 2011

  • Tec Milenio, Cd Juarez

    Master of Business Administration - MBA, Finance, General

    2015 — 2019

Skills

  • Quality System
  • Medical Devices
  • Capa
  • Dmaic
  • Lean Manufacturing
  • Microsoft Office
  • Iso 13485
  • Minitab
  • Validation
  • Fmea
  • Root Cause Analysis
  • Failure Mode and Effects Analysis (Fmea)
  • Six Sigma
  • Corrective and Preventive Action (Capa)
  • Cross-Functional Team Leadership
  • U.s. Food and Drug Administration (Fda)
  • Manufacturing

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Paulette Malacara — Sr, Manager Quality Management System, Emi at BD in Irvine, CA, US | Unifers