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.