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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
Vacancy posted 6 days ago
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