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 management
Design controls and risk management expertise
Regulatory compliance with 21 cfr part 4 and mdr
The role is responsible for leading the Global CP/MD Quality System ensuring compliance with regulations like 21 CFR Part 4 and ISO 13485 throughout the product lifecycle

Job Summary

  • The role is responsible for leading the Global CP/MD Quality System ensuring compliance with regulations like 21 CFR Part 4 and ISO 13485 throughout the product lifecycle.
  • This position requires managing R&D projects, vendor oversight, and developing a robust audit program for combination products and medical devices.
  • CSL Behring offers a competitive base salary range of $196,000-$232,000 along with incentive compensation and equity opportunities.

Matching Summary

The role is responsible for leading the Global CP/MD Quality System ensuring compliance with regulations like 21 CFR Part 4 and ISO 13485 throughout the product lifecycle.

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 management
  • Design Controls and risk management expertise
  • Regulatory compliance with 21 CFR Part 4 and MDR

Nice-to-have

  • Experience in pharmaceutical or biotech backgrounds
  • Strategic thinking for company-wide quality vision
  • Ability to work effectively in matrix organizations

Key Requirements

  • Bachelor's degree in engineering or life science
  • Minimum 10 years experience in medical device QA
  • Minimum 2 years people management experience

Work Rights

Not specified

Tailored Resume

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