Staff Npd Quality Engineer

Waters Corporation

San Diego, CA, USA
Base: $124,700.00 - $205,800.00 usd annual; bonus/...
Fully remote
Design control per fda 21 cfr part 820
Iso 13485 and ivdr regulatory compliance
Risk management using iso 14971 and fmea
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 position requires ensuring compliance with design control processes per FDA 21 CFR Part 820, ISO 13485, and IVDR.
  • Candidates will lead risk management activities including hazard analysis, FMEA, and risk mitigation strategies.

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 described

Skills & Requirements

Must-have

  • Design control per FDA 21 CFR Part 820
  • ISO 13485 and IVDR regulatory compliance
  • Risk management using ISO 14971 and FMEA
  • Verification and validation planning execution
  • Supplier qualification and quality oversight

Nice-to-have

  • Experience in companion diagnostics development
  • Background in flow cytometry or clinical assays
  • Strong cross-functional team collaboration skills
  • Proven ability to manage external partnerships
  • Excellent documentation and problem-solving skills

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter