Sr Quality Engineer

BD

Irvine, CA, USA
Base: $155,900.00 - $257,300.00 usd annual; bonus/...
Onsite
12 years engineering experience
Fda 21 cfr part 820 knowledge
Iso 13485 and mdr standards
BD is seeking a Sr Quality Engineer to lead advancements in quality engineering methodologies, focusing on product safety, efficacy, and compliance within the medical technology field. The ideal candidate will possess extensive experience with quality systems and regulatory standards, aiming to drive continuous improvement initiatives

Job Summary

  • This role serves as a recognized technical leader driving advancements in quality engineering methodologies across the global organization.
  • The position requires expert guidance on complex quality challenges throughout the product lifecycle from concept to post-market surveillance.
  • Candidates must demonstrate deep understanding of global medical device regulations including FDA, ISO, and MDR standards.

Matching Summary

Match Score: 85

BD is seeking a Sr Quality Engineer to lead advancements in quality engineering methodologies, focusing on product safety, efficacy, and compliance within the medical technology field. The ideal candidate will possess extensive experience with quality systems and regulatory standards, aiming to drive continuous improvement initiatives.

Salary

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

Skills & Requirements

Must-have

  • 12 years engineering experience
  • FDA 21 CFR Part 820 knowledge
  • ISO 13485 and MDR standards
  • Six Sigma and Lean methodologies
  • Risk management tools FMEA DFR
  • Statistical analysis software proficiency

Nice-to-have

  • Black Belt Six Sigma certification
  • Electro-mechanical systems expertise
  • Strong leadership and coaching skills
  • Experience with hemodynamic monitoring
  • Ability to travel domestically internationally

Key Requirements

  • Bachelor's degree in Engineering or Scientific field
  • 12 years of industry or education experience
  • Master's degree with 11 years experience OR Ph.D. with 8 years
  • End-to-end product lifecycle experience
  • US work authorization required

Work Rights

Not specified

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