Director, Quality Engineering

BDX

San Diego, CA, USA
Base: $179,200.00 - $322,500.00 usd annual; bonus/...
Fully remote
Quality engineering strategy development
Regulatory compliance with fda and iso 13485
Team leadership and mentorship
The Director, Quality Engineering will lead a team to ensure medical devices meet the highest standards of safety, efficacy, and regulatory compliance

Job Summary

  • The Director, Quality Engineering will lead a team to ensure medical devices meet the highest standards of safety, efficacy, and regulatory compliance.
  • BD values a culture where employees are supported to learn, grow, and become their best selves while driving innovation in healthcare.
  • The company offers a competitive compensation package and prioritizes on-site collaboration with a minimum of 4 days in-office per week to foster creativity and effective problem-solving.

Matching Summary

The Director, Quality Engineering will lead a team to ensure medical devices meet the highest standards of safety, efficacy, and regulatory compliance.

Salary

Base: $179,200.00 - $322,500.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive compensation and benefits programs

Skills & Requirements

Must-have

  • Quality engineering strategy development
  • Regulatory compliance with FDA and ISO 13485
  • Team leadership and mentorship
  • Design quality assurance and risk management
  • Process quality improvement and CAPA
  • Supplier quality management and auditing
  • Cross-functional collaboration

Nice-to-have

  • Strong interpersonal and communication skills
  • Data-driven problem-solving approach
  • High-performance culture fostering
  • Supportive learning and growth environment

Key Requirements

  • Bachelor's degree in Engineering or related scientific discipline
  • Minimum 10 years progressive Quality Engineering experience
  • At least 5 years leadership or management experience
  • In-depth knowledge of FDA 21 CFR Part 820 and ISO 13485
  • Proficiency in FMEA, SPC, MSA, Root Cause Analysis, CAPA
  • Preferred ASQ certifications such as CQE, CQM/OE, or Six Sigma Black Belt

Work Rights

Must be fully vaccinated against COVID-19 as condition of employment in some locations

Tailored Resume

Cover Letter