Associate Director, Quality Systems & Architecture

BD

San Diego, CA, USA
Base: $169,800.00 - $280,300.00 usd annual; bonus/...
Fully remote
10+ years quality regulatory operations experience
5+ years managing quality professionals
Expert-level qms knowledge and leadership
This role leads the QMS strategy including developing programs, policies, and controls for BD's global medical technology operations

Job Summary

  • This role leads the QMS strategy including developing programs, policies, and controls for BD's global medical technology operations.
  • The successful candidate will serve as the front room host for external audits and manage CAPA investigations to close organizational gaps.
  • BD offers a competitive salary range of $169,800.00 to $280,300.00 USD annually with a culture focused on innovation and collaboration.

Matching Summary

This role leads the QMS strategy including developing programs, policies, and controls for BD's global medical technology operations.

Salary

Base: $169,800.00 - $280,300.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive package including rewards and recognition programs

Skills & Requirements

Must-have

  • 10+ years Quality Regulatory Operations experience
  • 5+ years managing Quality professionals
  • Expert-level QMS knowledge and leadership
  • Experience leading FDA or Notified Body inspections
  • BS degree in Engineering Science Math or Stat

Nice-to-have

  • Regulatory Affairs experience preferred
  • Metrics data analytics statistical analysis skills
  • ASQ certifications CQE CSQE CRE CMQ/OE CSSGB CSSBB
  • Strong project management and team influence skills
  • Ability to travel up to 25% domestically internationally

Key Requirements

  • Minimum 10 years experience in Quality Regulatory or Operations
  • Minimum 5 years direct management experience
  • Bachelor of Science degree in technical field
  • Demonstrated expert-level knowledge of QMS
  • Proven ability to lead FDA and Notified Body inspections

Work Rights

Not specified

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