Regional Lead Quality Engineer

CSL Behring

Base: $143,000 - $169,000; bonus/equity: incentive...
21 cfr part 4 compliance expertise
Design control process management
Iso 13485 and eu mdr knowledge
The role leads a regional team to ensure new product development activities comply with FDA, EU MDR, and ISO standards

Job Summary

  • The role leads a regional team to ensure new product development activities comply with FDA, EU MDR, and ISO standards.
  • Candidates must possess at least five years of experience in quality or engineering within the medical device or combination product field.
  • Total compensation includes a base salary range of $143,000 to $169,000 plus potential incentive compensation and equity.

Matching Summary

The role leads a regional team to ensure new product development activities comply with FDA, EU MDR, and ISO standards.

Salary

Base: $143,000 - $169,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Not specified

Skills & Requirements

Must-have

  • 21 CFR Part 4 compliance expertise
  • Design Control process management
  • ISO 13485 and EU MDR knowledge
  • Vendor audit and management experience
  • Six Sigma problem solving skills
  • Risk analysis and FMEA application

Nice-to-have

  • Experience with drug-delivery products
  • Knowledge of embedded software systems
  • Connected health solutions background
  • Strong stakeholder influence skills
  • International travel availability

Key Requirements

  • Bachelor's degree in engineering or life sciences
  • Minimum 5 years medical device quality experience
  • Practical experience in R&D Quality and design controls

Work Rights

Not specified

Tailored Resume

Cover Letter