Senior Quality Engineer NPD
$79k - $127.65kJohnson & Johnson Medical Devices
Senior Quality Engineer supporting new product development at Johnson & Johnson's Irvine facility. Responsible for planning and executing quality assurance activities, design verification, process validation, and compliance throughout the product lifecycle in the medical device sector.
Responsibilities
- Collaborate with R&D and Operations on new product development and engineering projects
- Develop quality control plans, risk management documentation, and FMEA analyses
- Write and review validation protocols, equipment qualifications, and engineering change orders
- Perform statistical analysis and process capability studies to support manufacturing decisions
- Lead technical problem-solving, failure analysis, and root cause investigations
Requirements
- Bachelor's degree in engineering or scientific discipline
- Minimum 4 years quality, manufacturing, or R&D experience in medical device or regulated industry
- Proficiency with quality engineering tools and statistical methods (Six Sigma, SPC, DOE)
- Knowledge of design control requirements, risk management, and failure analysis
- Strong technical problem-solving and data analysis capabilities
- Experience with validation protocols, FMEA development, and regulatory compliance
Vacancy posted 6 days ago
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