Powell Zhang

Building Revolutionary Biowearables

Role
Senior Quality Manager at Biolinq
Location
San Diego, CA, US
LinkedIn followers
500 followers

About Powell Zhang

Self-driven and experienced Quality Engineering Leader working with regulated (FDA, EU MDR, ISO 13485) medical devices. Strong background in multiple Quality functions including Design Control, Verification/Validation (IQ/OQ/PQ/TMV), non-conformances, Risk Management, Calibration/Metrology, and Quality Management Systems.

Experience

  1. Senior Quality Manager

    Biolinq

    Mar 2024 — Present · San Diego, CA, US

    Operations Quality, Supplier Management, Risk Management, Design Quality, V&V

Education

  • University of Pennsylvania

    BSE, Biomedical Engineering

Skills

  • Cell
  • Six Sigma
  • Quality Assurance
  • Microscopy
  • Iso 13485
  • Material Review Board
  • Class Iii Medical Devices
  • Gmp
  • Iso 14971
  • Lean Six Sigma
  • Matlab
  • Medical Devices
  • Capa
  • Biomedical Engineering
  • Fda
  • Quality System
  • V&V
  • Risk Management
  • Fmea
  • Design Control
  • Validation
  • Quality System Compliance
  • Stem Cells
  • Post Market Surveillance
  • Cell Culture

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