Combination Products And Medical Devices Qa Lead

CSL Behring

Base: $196,000-$232,000; bonus/equity: incentive c...
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Global cp/md quality system development
Design controls compliance 21 cfr part 820
Iso 13485 and iso 14971 standards
** CSL Behring is seeking an Associate Director for Quality Assurance in Combination Products and Medical Devices, responsible for leading global quality initiatives and ensuring compliance with relevant regulations. The ideal candidate should possess extensive experience in quality management within the medical device industry, along with strong leadership skills. **

Job Summary

  • The Associate Director is responsible for leading the Global CP/MD Quality department to support the design, development, manufacture, and regulatory approval of CSL combination products.
  • This role requires developing and implementing a comprehensive Quality System compliant with 21 CFR Part 4, 21 CFR Part 820, MDD/MDR, and ISO 13485 throughout the entire product lifecycle.
  • CSL Behring offers a competitive base salary range of $196,000-$232,000 along with incentive compensation, equity, and a culture focused on inclusion and belonging.

Matching Summary

Match Score: 75

** CSL Behring is seeking an Associate Director for Quality Assurance in Combination Products and Medical Devices, responsible for leading global quality initiatives and ensuring compliance with relevant regulations. The ideal candidate should possess extensive experience in quality management within the medical device industry, along with strong leadership skills. **

Salary

Base: $196,000-$232,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Comprehensive well-being programs and inclusion initiatives

Skills & Requirements

Must-have

  • Global CP/MD Quality System development
  • Design Controls compliance 21 CFR Part 820
  • ISO 13485 and ISO 14971 standards
  • EU MDD/MDR regulatory knowledge
  • Vendor qualification and audit management
  • Risk management including FMEA
  • New product development lifecycle oversight

Nice-to-have

  • Strategic thinking in matrix organization
  • Experience with Connected Health platforms
  • Cross-functional team leadership skills
  • Budgeting and financial management experience
  • Multi-site location management preference

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 FDA and EU regulations
  • Experience managing multi-site locations preferred

Work Rights

Not specified

Tailored Resume

Cover Letter