Sr. Quality Engineer

BD

Carol Stream, IL, United States
Base: $92,700.00 - $152,900.00 usd annual; bonus/e...
Fully remote
Quality system implementation and maintenance
Design control and risk management
Root cause analysis and capa execution
The Sr. Quality Engineer will be responsible for ensuring the quality and reliability of Bard Brachytherapy products through advanced quality engineering principles and methodologies

Job Summary

  • The Sr. Quality Engineer will be responsible for ensuring the quality and reliability of Bard Brachytherapy products through advanced quality engineering principles and methodologies.
  • This role plays a critical part in maintaining compliance with all relevant regulations and standards throughout the product lifecycle.
  • At BD, you’ll discover a culture in which you can learn, grow, and thrive, and find satisfaction in doing your part to make the world a better place.

Matching Summary

The Sr. Quality Engineer will be responsible for ensuring the quality and reliability of Bard Brachytherapy products through advanced quality engineering principles and methodologies.

Salary

Base: $92,700.00 - $152,900.00 USD Annual; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Quality System implementation and maintenance
  • Design control and risk management
  • Root cause analysis and CAPA execution
  • FDA QSR 21 CFR Part 820 compliance
  • ISO 13485 and EU MDR standards
  • Quality audits and metrics reporting

Nice-to-have

  • Mentorship and leadership in quality
  • Statistical software proficiency
  • Cross-functional collaboration
  • Strong communication skills
  • Regulatory submission support

Key Requirements

  • Bachelor's degree in Engineering
  • 5+ years Quality Engineering experience
  • Experience in medical device industry
  • Knowledge of FDA QSR and ISO 13485
  • Experience with design controls and risk management
  • Ability to lead root cause investigations
  • ASQ certifications preferred

Work Rights

Not specified

Tailored Resume

Cover Letter