New Product Quality Engineer Ii

Johnson & Johnson Innovative Medicine

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.
  • As part of a cross-functional team, the New Product QE performs quality and technical functions associated with new ophthalmic product development, including supporting early technology research and guiding project teams through Quality system requirements.
  • Johnson & Johnson is responsible to our employees who work with us throughout the world, providing an inclusive work environment where each person is considered as an individual and their diversity and dignity are respected.

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)
  • ophthalmic product development

Nice-to-have

  • Customer Centricity
  • Data Savvy
  • Execution Focus
  • Technologically Savvy
  • Lean Supply Chain Management

Key Requirements

  • Minimum of 2 years medical device industry experience
  • Bachelor's or equivalent degree in Math, Statistics, Engineering or Science
  • Working knowledge of Teamcenter (Siemens PLM)
  • Working knowledge of Design of Experiments

Work Rights

Not specified

Tailored Resume

Cover Letter