Staff Quality Engineer NPD
Johnson & Johnson Medical Devices
Staff Quality Engineer for new product development at Johnson & Johnson's Irvine facility. The role leads quality assurance activities across product lifecycles, manages NPD teams, and ensures compliance with quality systems and regulatory standards.
Responsibilities
- Oversee quality assurance activities and processes throughout product development lifecycle
- Develop and implement risk management plans, failure mode analyses, and validation protocols
- Lead quality improvement initiatives and non-conformance report processes for facilities
- Conduct statistical analysis and apply Six Sigma tools to improve process capability
- Support design control activities, sterility testing, and manufacturing transfer for new products
Requirements
- Bachelor's degree required, preferably in engineering or scientific discipline
- Minimum 6 years of quality, manufacturing, or research and development experience
- Master's degree preferred
- Expertise in quality engineering tools and statistical analysis methods
- Knowledge of design control requirements and regulatory standards
- Leadership experience managing quality engineering teams
$95.8k - $159.6k
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