Marco Hernandez

Senior Manager, Quality Systems & Regulatory Compliance at Arthrex, Inc.

Role
Senior Manager, Quality Systems & Regulatory Compliance at Arthrex
Location
Naples, FL, US
LinkedIn followers
500 followers
Manufacturing & ProductionView LinkedIn profile

About Marco Hernandez

Experienced Quality Systems and Regulatory Compliance leader with a demonstrated history…

Experience

  1. Senior Manager, Quality Systems & Regulatory Compliance

    Arthrex

    Sep 2019 — Present · Naples, FL, US

Education

  • Ashford University

    Bachelor of Arts - BA, Business Leadership

  • Universidad de Costa Rica UCR

    Bachelor of Arts - BA, Music Composition and Direction of Orchestra

    1989 — 1991

Skills

  • U.s. Food and Drug Administration (Fda)
  • Iso 13485
  • Oracle Agile Plm
  • Corrective and Preventive Action (Capa)
  • Design Control
  • Continuous Improvement
  • Research and Development (R&D)
  • Regulatory Submissions
  • Iso
  • Business Process Improvement
  • Fda
  • Software Documentation
  • R&D
  • Root Cause Analysis
  • Validation
  • Cross-Functional Team Leadership
  • Iso 14971
  • Verification and Validation (V&V)
  • Quality Management
  • Quality Assurance
  • Design for Manufacturing
  • Lean Manufacturing
  • Management
  • Medical Devices
  • Capa
  • Iso 9000
  • Quality System
  • V&V
  • Regulatory Affairs
  • Change Control
  • 21 Cfr Part 11
  • Process Improvement
  • Quality Control
  • Six Sigma
  • Gxp
  • Gmp
  • Quality Auditing
  • Iso Standards
  • Computer System Validation

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Marco Hernandez — Senior Manager, Quality Systems & Regulatory Compliance at Arthrex in Naples, FL, US | Unifers