At Johnson & Johnson, we believe health is everything and strive to innovate across the full spectrum of healthcare solutions to deliver breakthroughs that profoundly impact health for humanity
Job Summary
At Johnson & Johnson, we believe health is everything and strive to innovate across the full spectrum of healthcare solutions to deliver breakthroughs that profoundly impact health for humanity.
The Quality Engineering Executive is responsible for ensuring product quality, regulatory compliance, and effective quality system implementation for manufacturing operations in compliance with global medical device regulations.
This role supports risk management, product master data governance, inspection controls, continuous improvement, and partners with R&D and cross-functional teams to address design controls and risk management.
Matching Summary
At Johnson & Johnson, we believe health is everything and strive to innovate across the full spectrum of healthcare solutions to deliver breakthroughs that profoundly impact health for humanity.
Skills & Requirements
Must-have
Quality system implementation
Regulatory compliance with ISO13485
Risk management and pFMEA
Statistical and data analysis
Product master data governance
Design verification and validation
Process Excellence and Lean principles
Nice-to-have
Cross-functional collaboration with R&D
Continuous improvement initiatives
Change management system experience
Audit participation and compliance
Control plan development
Facility and utility qualification review
Key Requirements
Compliance with ISO 13485 and global regulations
Experience with medical device quality systems
Knowledge of ISO 14971 risk management
Experience in validation and verification activities