Staff Quality Engineer - Quality Lcm

Johnson & Johnson

Irvine, California, United States of America
Base: $125,000 - $150,000; bonus/equity: long-term...
Life cycle management (lcm) expertise
Design verification and process validation
Fda, iso 13485, cmdcas, pmda compliance
The role involves serving as a subject matter expert on Quality LCM matters for Johnson & Johnson's Biosense Webster division

Job Summary

  • The role involves serving as a subject matter expert on Quality LCM matters for Johnson & Johnson's Biosense Webster division.
  • Candidates will lead design verification tests and ensure compliance with FDA, ISO 13485, and other global regulatory standards.
  • The position offers a competitive salary range of $125,000 to $150,000 along with comprehensive benefits including 401(k) and parental leave.

Matching Summary

The role involves serving as a subject matter expert on Quality LCM matters for Johnson & Johnson's Biosense Webster division.

Salary

Base: $125,000 - $150,000; Bonus/Equity: Long-term incentive program eligible; Benefits: Medical, dental, vision, 401(k), pension, and extensive time off

Skills & Requirements

Must-have

  • Life Cycle Management (LCM) expertise
  • Design verification and process validation
  • FDA, ISO 13485, CMDCAS, PMDA compliance
  • Statistical analysis using Six Sigma SPC DOE
  • Manufacturing transfer and project management

Nice-to-have

  • Collaboration with cross-functional teams
  • Experience with electrophysiology catheters
  • Telecommute flexibility available

Key Requirements

  • Master's degree in Mechanical or Biomedical Engineering
  • 4 years of experience in Staff Quality Engineer role
  • Knowledge of medical device regulatory requirements

Work Rights

Not specified

Tailored Resume

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