Combination Products And Medical Devices Qa Lead

CSL

Waltham, MA, United States
Base: $196,000- $232,000; bonus/equity: not specif...
On-site
Global cp/md quality system development
Design controls for combination products
Cp/md vendor management
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

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

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.

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
  • CP/MD vendor management
  • Internal auditing program
  • Regulatory requirements monitoring
  • Quality oversight of vendors

Nice-to-have

  • Strategic initiatives participation
  • Cross-functional initiatives leadership
  • Quality culture driving

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter