Combination Products And Medical Devices Qa Lead

CSL Behring

Waltham, MA, United States
Base: $196,000- $232,000; bonus/equity: not specif...
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Combination products and medical devices qa
Global quality system development
Design controls and risk management
** CSL Behring is seeking an Associate Director to lead its Quality Assurance department for Combination Products and Medical Devices. The role involves developing and managing the quality system, ensuring compliance with regulatory standards, and participating in strategic decision-making. **

Job Summary

  • The Associate Director is responsible for leading Quality for Combination Products and Medical Devices (CP/MD QA) global department that supports design, development, manufacture and regulatory approval of CSL combination products.
  • This role is accountable for the development, execution, and performance of the Global CP/MD Quality System for combination products in compliance with applicable regulations.
  • The Associate Director is expected to take part in defining the overall company strategy for the combination products, as well as the strategy for the CSL Global Quality.

Matching Summary

Match Score: 75

** CSL Behring is seeking an Associate Director to lead its Quality Assurance department for Combination Products and Medical Devices. The role involves developing and managing the quality system, ensuring compliance with regulatory standards, and participating in strategic decision-making. **

Salary

Base: $196,000- $232,000; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Combination Products and Medical Devices QA
  • Global Quality System development
  • Design Controls and Risk Management
  • Vendor Management and Auditing
  • Regulatory Compliance (21 CFR Part 4, 820, ISO 13485, MDR)

Nice-to-have

  • Strategic company vision
  • Cross-functional initiative leadership
  • Quality culture promotion

Key Requirements

  • Minimum 10 years experience in medical devices or combination products
  • Minimum 2 years people management experience
  • Bachelor's degree in engineering or life science

Work Rights

Not specified

Tailored Resume

Cover Letter