Senior Quality Engineer

Johnson & Johnson

Irvine, California, United States
$79,000.00 - $127,650.00; not specified; not speci...
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New product development (npd)
Design verification tests
Process validations
** Johnson & Johnson is seeking a Senior Quality Engineer for its Biosense Webster division in Irvine, California. The ideal candidate will have extensive experience in quality assurance within the medical device industry and will be responsible for overseeing quality processes throughout the product lifecycle. **

Job Summary

  • The Senior Quality Engineer plans, coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of a product.
  • Key responsibilities include collaborating with functional groups, using Quality Engineering tools, overseeing the Non-Conformance Report (NCR) process, and developing risk management plans.
  • The role requires a minimum of 4 years of experience in a regulated industry, with a Bachelor's degree in engineering or a scientific field, and proficiency in statistical analysis and quality engineering methodologies.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Senior Quality Engineer for its Biosense Webster division in Irvine, California. The ideal candidate will have extensive experience in quality assurance within the medical device industry and will be responsible for overseeing quality processes throughout the product lifecycle. **

Salary

$79,000.00 - $127,650.00; Not specified; Not specified

Skills & Requirements

Must-have

  • New Product Development (NPD)
  • design verification tests
  • process validations
  • risk management document development
  • catheter test methods
  • statistical tools analysis
  • failure analysis
  • root cause determination

Nice-to-have

  • collaborating with R&D and Operations
  • influencing and negotiating outcomes
  • innovating compliant approaches

Key Requirements

  • Bachelor’s degree in engineering or scientific field
  • Minimum of 4 years of quality, manufacturing, or R&D experience
  • Experience in medical device or regulated industry
  • Ability to define problems and analyze data
  • Project management skills
  • Proven auditing and problem-solving skills
  • Understanding of experimental engineering techniques
  • Six Sigma/Design for Six Sigma experience
  • Lean manufacturing experience
  • Knowledge of GMP
  • Geometrical Dimensioning and Tolerancing (GD&T) experience

Work Rights

Not specified

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