Staff Quality Engineer - Combination Products

BDX

Tempe, AZ, United States
Fully remote
Medical device manufacturing knowledge
Risk management and assessment skills
Test method development and validation
This position supports product leadership and risk management of new product development and sustaining activities for combination products

Job Summary

  • This position supports product leadership and risk management of new product development and sustaining activities for combination products.
  • BD is one of the largest global medical technology companies in the world advancing the world of health through transformative solutions.
  • At BD, you’ll discover a culture in which you can learn, grow, and thrive while making the world a better place.

Matching Summary

This position supports product leadership and risk management of new product development and sustaining activities for combination products.

Skills & Requirements

Must-have

  • Medical device manufacturing knowledge
  • Risk management and assessment skills
  • Test method development and validation
  • Quality engineering tools application
  • Cross functional team leadership
  • Regulatory compliance knowledge
  • Manufacturing control plan development

Nice-to-have

  • Strong interpersonal skills
  • Problem solving ability
  • Oral and written presentation skills
  • Ability to create and provide training
  • Ability to generate engineering proposals
  • Experience with ISO and FDA regulations
  • Team-oriented fast-paced environment

Key Requirements

  • BS in Engineering or related field
  • Masters or Ph.D preferred
  • Minimum eight years engineering or quality experience
  • Pharmaceutical or combination product experience preferred
  • Quality Engineering Certification (ASQ) preferred
  • Ability to travel up to 25%
  • Knowledge of ISO 13485, ISO 14971, 21 CFR 210/211/820, ICH Guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter