Regional Lead Quality Engineer

CSL Behring

Base: $143,000 - $169,000; bonus/equity: incentive...
5 years medical device experience
Design control process expertise
21 cfr part 4 compliance knowledge
This role leads a regional team to ensure all new product development activities comply with FDA, EU MDR, and global regulatory requirements

Job Summary

  • This role leads a regional team to ensure all new product development activities comply with FDA, EU MDR, and global regulatory requirements.
  • The position involves overseeing the entire product lifecycle from concept to post-market support with a specific emphasis on Design Control processes.
  • CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies and a culture of inclusion and belonging.

Matching Summary

This role leads a regional team to ensure all new product development activities comply with FDA, EU MDR, and global regulatory requirements.

Salary

Base: $143,000 - $169,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Comprehensive well-being programs offered

Skills & Requirements

Must-have

  • 5 years medical device experience
  • Design control process expertise
  • 21 CFR Part 4 compliance knowledge
  • ISO 13485 and ISO 14971 standards
  • Vendor management and audit skills
  • Six Sigma problem solving techniques

Nice-to-have

  • Experience with drug-delivery products
  • Knowledge of embedded software validation
  • Familiarity with connected health solutions
  • Strong stakeholder influence skills
  • Global cross-functional collaboration

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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