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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Global cp/md quality system development
Design controls for combination products
Medical device and combination product regulations
** CSL Behring is seeking an Associate Director for their Combination Products and Medical Devices Quality Assurance team, responsible for leading quality initiatives, developing a global quality system, and ensuring compliance with regulatory standards. The ideal candidate should have significant experience in quality management within the medical device industry, along with strong leadership and communication skills. **

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 for their Combination Products and Medical Devices Quality Assurance team, responsible for leading quality initiatives, developing a global quality system, and ensuring compliance with regulatory standards. The ideal candidate should have significant experience in quality management within the medical device industry, along with strong leadership and communication skills. **

Salary

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

Skills & Requirements

Must-have

  • Global CP/MD Quality System development
  • Design Controls for combination products
  • Medical device and combination product regulations
  • Vendor management for quality oversight
  • Internal auditing program development

Nice-to-have

  • Strategic company strategy definition
  • Cross-functional initiative leadership
  • Quality culture promotion

Key Requirements

  • Bachelor’s degree in engineering or life science
  • Minimum 10 years of experience in medical devices or combination products
  • Minimum 2 years of people management experience
  • Experience in budgeting and financial management preferred

Work Rights

Not specified

Tailored Resume

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