Distinguished Quality Engineer

Becton, Dickinson and Company

Irvine, CA, USA
Base: $155,900.00 - $257,300.00 usd annual; bonus/...
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12 years experience in engineering or scientific field
Expertise in fda 21 cfr part 820 and iso 13485
Advanced statistical analysis using minitab or jmp
** Becton, Dickinson and Company is seeking a Distinguished Quality Engineer to lead advancements in quality engineering methodologies and practices. The ideal candidate will possess extensive experience in quality assurance within the medical technology field, showcasing skills in risk management and regulatory compliance. **

Job Summary

  • This role serves as a recognized technical leader driving significant advancements in quality engineering methodologies across the organization.
  • The successful candidate will represent the organization as a subject matter expert during regulatory audits including FDA and ISO inspections.
  • BD offers a comprehensive Total Rewards program designed to attract and retain high-quality talent through competitive compensation and benefits.

Matching Summary

Match Score: 75

** Becton, Dickinson and Company is seeking a Distinguished Quality Engineer to lead advancements in quality engineering methodologies and practices. The ideal candidate will possess extensive experience in quality assurance within the medical technology field, showcasing skills in risk management and regulatory compliance. **

Salary

Base: $155,900.00 - $257,300.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program including performance-based culture

Skills & Requirements

Must-have

  • 12 years experience in engineering or scientific field
  • Expertise in FDA 21 CFR Part 820 and ISO 13485
  • Advanced statistical analysis using Minitab or JMP
  • Risk management tools like FMEA and Fault-Tree Analysis
  • End-to-end product lifecycle experience from development to post-market

Nice-to-have

  • Black Belt Six Sigma certification
  • Experience with electro-mechanical hemodynamic systems
  • Ability to travel domestically and internationally
  • Strong negotiation and relationship management skills
  • Participation in industry forums and advisory boards

Key Requirements

  • Bachelor's degree in Engineering or Scientific field with 12 years experience
  • Master's degree in Engineering or Scientific field with 11 years experience
  • Ph.D. in Engineering or Scientific field with 8 years experience
  • Deep understanding of global medical device regulations (MDR, MDSAP)
  • Proven track record leading quality improvement initiatives

Work Rights

Not specified

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