New Product Quality Engineer Ii

J&J FAMILY OF COMPANIES

Jacksonville, Florida, United States of America
Hybrid
Design controls and risk management
Design verification and validation
Process validation (iq/oq/pq)
The New Product Quality Engineer (Engineer II) ensures that new products are safe, effective, and compliant with applicable regulatory standards from early-stage R&D concepts to transfer to manufacturing and ultimately, product launch

Job Summary

  • The New Product Quality Engineer (Engineer II) ensures that new products are safe, effective, and compliant with applicable regulatory standards from early-stage R&D concepts to transfer to manufacturing and ultimately, product launch.
  • Key responsibilities include supporting early technology research, guiding project teams through Quality system requirements, and contributing to the development, review, and execution of protocols for design verification and validation.
  • The role also involves actively supporting qualification projects, creating and archiving technical documentation, and serving as the Quality lead for pre- and post-launch product design changes.

Matching Summary

The New Product Quality Engineer (Engineer II) ensures that new products are safe, effective, and compliant with applicable regulatory standards from early-stage R&D concepts to transfer to manufacturing and ultimately, product launch.

Skills & Requirements

Must-have

  • Design Controls and Risk Management
  • Design Verification and Validation
  • Process Validation (IQ/OQ/PQ)
  • Design History File (DHF)
  • Medical Device File (MDF)

Nice-to-have

  • Customer Centricity
  • Data Savvy
  • Execution Focus
  • Technologically Savvy

Key Requirements

  • Minimum of 2 years medical device industry experience
  • Bachelor's or equivalent degree in STEM
  • Understanding of GMP/ISO medical device regulation

Work Rights

Not specified

Tailored Resume

Cover Letter