Regional Lead Quality Engineer

CSL Behring

Base: $143,000 - $169,000; bonus/equity: incentive...
**
21 cfr part 4 compliance expertise
Design control process management
Risk analysis and fmea application
** CSL Behring is seeking a Regional Lead Quality Engineer to oversee a team focused on the quality assurance of medical devices and combination products. The role entails ensuring compliance with FDA, EU MDR, and ISO regulations throughout the product lifecycle, while collaborating with global teams and managing vendor relationships. **

Job Summary

  • The role ensures new product development activities follow a 21 CFR Part 4 compliant quality system in accordance with FDA and MDR regulations.
  • This position provides guidance to local staff and collaborates with global functions to govern quality-related business processes throughout the entire combination product lifecycle.
  • Total compensation includes base salary ranging from $143,000 to $169,000 plus potential incentive compensation and equity.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Regional Lead Quality Engineer to oversee a team focused on the quality assurance of medical devices and combination products. The role entails ensuring compliance with FDA, EU MDR, and ISO regulations throughout the product lifecycle, while collaborating with global teams and managing vendor relationships. **

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
  • Risk analysis and FMEA application
  • Vendor audit and management skills
  • Six Sigma problem solving techniques

Nice-to-have

  • Experience with drug-delivery products
  • Knowledge of embedded software systems
  • Connected health solutions experience
  • 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