Jobs · Quality Assurance · California

Quality Engineer - Medical Devices (Senior NPD/NPI)

Plan A Health · Irvine, CA · 4 wk ago
Quality AssuranceFull-time

About the role

Ensure design quality and regulatory compliance throughout new product development (NPD) and new product introduction (NPI) for Masimo Wearables.

Responsibilities

  • Support cross-functional teams with design control, risk management, and verification/validation activities.
  • Ensure successful product launches by maintaining quality standards and regulatory adherence.
  • Collaborate with Regulatory Affairs, R&D, Operations, and Supply Chain to align quality processes.

Requirements

  • Extensive experience in regulated medical devices and Quality Management Systems (QMS).
  • Strong understanding of design control, risk management, and validation procedures.
  • Excellent collaboration and communication abilities across technical teams.

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