Scott McKently

Director, Investigations (Systems)

Role
Regeneron
Location
Troy, NY, US
LinkedIn followers
500 followers

About Scott McKently

Results oriented Quality Assurance/ Regulatory Affairs (QA/RA) Professional with an…

Experience

  1. Regeneron

    Present

Education

  • University of Pennsylvania

    MS, Organizational Dynamics

    2002 — 2006

  • Lehigh University

    MS, Manufacturing Systems Engineering

    1997 — 1999

  • Penn State University

    Bachelor's degree, Mechanical Engineering/Mechanical Technology/Technician

Skills

  • Design Control
  • Validation
  • Dmaic
  • Leadership
  • Disposables
  • 21 Cfr Part 11
  • Minitab
  • Iso 13485
  • Medical Device Directive
  • Ce Marking
  • Change Control
  • Regulatory Affairs
  • Gmp
  • Continuous Improvement
  • 21 Cfr
  • Cardiology
  • Fda
  • Biomedical Engineering
  • Cqa
  • Supplier Quality
  • Iso 14971
  • R&D
  • Fmea
  • Spc
  • Quality System
  • V&V
  • Quality Assurance
  • Pma
  • Root Cause Analysis
  • Biocompatibility
  • Six Sigma
  • Medical Devices
  • Capa
  • Design of Experiments
  • Catheters
  • Fda Gmp

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