Staff Quality Engineer - Combination Products

BD

Tempe, AZ, United States
Fully remote
Quality engineering tools application
Risk management and assessment leadership
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, committed to advancing the world of health through innovation and teamwork.
  • The role offers opportunities to learn, grow, and contribute in a culture that values diversity, accountability, and continuous improvement.

Matching Summary

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

Skills & Requirements

Must-have

  • Quality engineering tools application
  • Risk management and assessment leadership
  • Test method development and validation
  • Manufacturing and quality system optimization
  • Cross functional team leadership
  • Regulatory compliance and submissions support
  • Travel up to 25% required

Nice-to-have

  • Strong interpersonal and presentation skills
  • Problem solving and training abilities
  • Experience with chemical and pharmaceutical operations
  • Ability to work in fast-paced team environment
  • Understanding of ISO and FDA regulatory standards

Key Requirements

  • BS in Engineering or related field required; Masters or Ph.D preferred
  • Minimum eight years quality or engineering experience in medical device or pharmaceutical industry
  • Pharmaceutical or combination product experience preferred
  • Knowledge of ISO 13485, ISO 14971, 21 CFR 210/211/820, and ICH Guidelines
  • Quality Engineering Certification (ASQ) preferred

Work Rights

Not specified

Tailored Resume

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