Combination Products And Medical Devices Qa Lead

CSL Behring

Base: $196,000-$232,000; bonus/equity: incentive c...
Fully remote
10+ years medical device quality experience
Design controls implementation expertise
Iso 13485 and fda 21 cfr part 820 knowledge
The role is responsible for leading the Global CP/MD Quality System to ensure compliance with international regulations throughout the product lifecycle

Job Summary

  • The role is responsible for leading the Global CP/MD Quality System to ensure compliance with international regulations throughout the product lifecycle.
  • This position requires developing and implementing Design Control processes that incorporate risk analysis and statistical data analysis for new product development.
  • CSL Behring offers a competitive base salary range of $196,000-$232,000 along with incentive compensation, equity, and comprehensive benefits.

Matching Summary

The role is responsible for leading the Global CP/MD Quality System to ensure compliance with international regulations throughout the product lifecycle.

Salary

Base: $196,000-$232,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Comprehensive health and well-being support mentioned

Skills & Requirements

Must-have

  • 10+ years medical device quality experience
  • Design Controls implementation expertise
  • ISO 13485 and FDA 21 CFR Part 820 knowledge
  • Global Quality System development and management
  • Risk management and FMEA application
  • Vendor qualification and audit program leadership

Nice-to-have

  • Experience with EU MDR regulations
  • Strategic planning in matrix organizations
  • Cross-functional team collaboration skills
  • Budgeting and financial management experience
  • Multi-site location management background

Key Requirements

  • Bachelor's degree in engineering or life science
  • Minimum 10 years in medical device quality
  • Minimum 2 years people management experience
  • Proficiency in English and MS Office applications

Work Rights

Not specified

Tailored Resume

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