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 820
CSL Behring is seeking an Associate Director for Quality Assurance in Combination Products and Medical Devices, responsible for leading global quality initiatives in compliance with regulations. The ideal candidate will have extensive experience in the medical device industry and a strong background in quality systems, with a focus on new product development

Job Summary

  • The Associate Director is responsible for leading the Global CP/MD Quality System to ensure compliance with regulations throughout the entire combination product lifecycle.
  • This role requires extensive practical experience in medical device R&D quality, including design controls, risk management, and validation activities.
  • CSL Behring offers a competitive base salary range of $196,000-$232,000 along with incentive compensation and equity opportunities.

Matching Summary

Match Score: 85

CSL Behring is seeking an Associate Director for Quality Assurance in Combination Products and Medical Devices, responsible for leading global quality initiatives in compliance with regulations. The ideal candidate will have extensive experience in the medical device industry and a strong background in quality systems, with a focus on new product development.

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 820
  • ISO 13485 and EU MDR knowledge
  • Vendor qualification and audit processes
  • New product development lifecycle oversight

Nice-to-have

  • Strategic thinking and planning capabilities
  • Experience in matrix organization collaboration
  • Budgeting and financial management skills
  • Multi-site location management experience
  • Strong critical reasoning and problem solving

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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