Combination Products And Medical Devices Qa Lead

CSL Ltd

Waltham, MA, United States
Base: $196,000- $232,000; bonus/equity: not specif...
On-site
Combination products and medical devices qa
Global quality system development and execution
21 cfr part 4 and 21 cfr part 820 compliance
CSL Ltd is seeking an Associate Director to lead the Quality Assurance for Combination Products and Medical Devices in Waltham, MA. The role involves developing quality systems, ensuring regulatory compliance, and managing quality oversight throughout the product lifecycle

Job Summary

  • The Associate Director is responsible for leading the 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 combination products, as well as the strategy for CSL Global Quality.

Matching Summary

Match Score: 85

CSL Ltd is seeking an Associate Director to lead the Quality Assurance for Combination Products and Medical Devices in Waltham, MA. The role involves developing quality systems, ensuring regulatory compliance, and managing quality oversight throughout the product lifecycle.

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 and execution
  • 21 CFR Part 4 and 21 CFR Part 820 compliance
  • ISO 13485 and MDD/MDR regulations
  • Design Controls and Risk Management
  • Vendor Management and Auditing
  • R&D/Technical Development project oversight

Nice-to-have

  • Strategic company vision contribution
  • Cross-functional initiative leadership
  • Quality culture promotion
  • Budget and resource management

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter