Staff Npd Quality Engineer

BD

San Diego, CA, USA
Base: $124,700.00 - $205,800.00 usd annual; bonus/...
Fully remote
Ivd product development experience
Design control per fda 21 cfr part 820
Iso 13485 and ivdr regulatory compliance
This role involves serving as the Quality representative on cross-functional teams for Companion Diagnostics development projects

Job Summary

  • This role involves serving as the Quality representative on cross-functional teams for Companion Diagnostics development projects.
  • The successful candidate will ensure compliance with design control processes per FDA 21 CFR Part 820, ISO 13485, and IVDR.
  • Waters is a global leader in life sciences dedicated to accelerating the benefits of pioneering science through analytical technologies.

Matching Summary

This role involves serving as the Quality representative on cross-functional teams for Companion Diagnostics development projects.

Salary

Base: $124,700.00 - $205,800.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive package including well-being and development rewards

Skills & Requirements

Must-have

  • IVD product development experience
  • Design control per FDA 21 CFR Part 820
  • ISO 13485 and IVDR regulatory compliance
  • Risk management using ISO 14971
  • Verification and validation planning

Nice-to-have

  • Companion diagnostics background
  • Flow cytometry or clinical assays knowledge
  • Cross-functional team collaboration skills
  • Strong communication and problem-solving abilities

Key Requirements

  • Bachelor's degree in Engineering or Life Sciences
  • Minimum 5 years of experience in Quality Engineering within IVD or medical device industry
  • Master's degree preferred

Work Rights

Not specified

Tailored Resume

Cover Letter