Combination Products And Medical Devices Qa Lead

CSL Behring

Base: $196,000-$232,000; bonus/equity: incentive c...
Fully remote
Global cp/md quality system development
Design controls compliance with 21 cfr part 820
Risk management using iso 14971
CSL Behring is seeking an Associate Director for their Combination Products and Medical Devices Quality Assurance team, responsible for leading the global quality system and ensuring compliance with regulatory standards throughout the product lifecycle. The ideal candidate will have extensive experience in quality management within the medical devices or combination products industry and demonstrated leadership skills

Job Summary

  • The role is accountable for the development and execution of a Global CP/MD Quality System ensuring compliance with FDA, MDR, and ISO regulations throughout the product lifecycle.
  • This position requires leading a global team to oversee R&D projects, manage vendor relationships, and drive strategic initiatives for combination products and connected health solutions.
  • 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: 85

CSL Behring is seeking an Associate Director for their Combination Products and Medical Devices Quality Assurance team, responsible for leading the global quality system and ensuring compliance with regulatory standards throughout the product lifecycle. The ideal candidate will have extensive experience in quality management within the medical devices or combination products industry and demonstrated leadership skills.

Salary

Base: $196,000-$232,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Not specified

Skills & Requirements

Must-have

  • Global CP/MD Quality System development
  • Design Controls compliance with 21 CFR Part 820
  • Risk Management using ISO 14971
  • Vendor qualification and audit processes
  • ISO 13485 and EU MDR regulatory knowledge
  • New product development lifecycle oversight

Nice-to-have

  • Experience in pharmaceutical or biotech backgrounds
  • Strategic thinking for global quality vision
  • Cross-functional team leadership skills
  • Budgeting and financial management experience
  • Multi-site location management experience

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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