Senior Quality Engineer

Johnson & Johnson

Jacksonville, Florida, United States of America
Base: $79,000.00 - $127,650.00; bonus/equity: elig...
Computer software validation (csv) project planning
Fda qsr and iso medical device regulations
Gamp5 and sdlc working knowledge
The Senior Software Quality Engineer applies tools and practices for the effective development and maintenance of manufacturing processes throughout the product lifecycle

Job Summary

  • The Senior Software Quality Engineer applies tools and practices for the effective development and maintenance of manufacturing processes throughout the product lifecycle.
  • This role involves supporting Computer Software Validation projects including the creation of URS, SDS, and RTM documents while reviewing qualification protocols and risk analysis.
  • Johnson & Johnson offers a comprehensive benefits package including up to 480 hours of parental leave, 13 days of holiday pay, and eligibility for long-term incentive programs.

Matching Summary

The Senior Software Quality Engineer applies tools and practices for the effective development and maintenance of manufacturing processes throughout the product lifecycle.

Salary

Base: $79,000.00 - $127,650.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: 401(k), pension, vacation, sick time, parental leave

Skills & Requirements

Must-have

  • Computer Software Validation (CSV) project planning
  • FDA QSR and ISO medical device regulations
  • GAMP5 and SDLC working knowledge
  • Part 11 electronic records and signatures
  • SCADA, PLC, HMI, Vision Systems, MES experience
  • Change Control Board participation

Nice-to-have

  • IQ, OQ, PQ process validation experience
  • Notified body inspection experience
  • CSQE or CQE certification
  • Root cause investigation skills
  • Technical writing and communication

Key Requirements

  • Bachelor's Degree in Engineering, CS, or STEM
  • Minimum 6 years experience in regulated environment
  • Experience with Medical Device or Pharmaceutical industry
  • Knowledge of FDA and European medical device regulations

Work Rights

Not specified

Tailored Resume

Cover Letter