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 and execution
Design controls and risk management
** CSL Behring is seeking an Associate Director for Quality Assurance in Combination Products and Medical Devices at their Waltham, MA location. This leadership role entails overseeing global quality systems, compliance with regulatory standards, and managing a team to ensure high-quality development and monitoring of medical devices. **

Job Summary

  • The Associate Director leads the Global CP/MD Quality System for combination products, ensuring compliance with regulations throughout the product lifecycle, with an emphasis on new product development.
  • This role is accountable for developing, implementing, and managing the Global CP/MD Quality System, including Design Controls, risk management, and vendor management.
  • The position requires providing QA oversight for R&D/Technical Development projects, ensuring compliance with applicable regulatory requirements and standards.

Matching Summary

Match Score: 75

** CSL Behring is seeking an Associate Director for Quality Assurance in Combination Products and Medical Devices at their Waltham, MA location. This leadership role entails overseeing global quality systems, compliance with regulatory standards, and managing a team to ensure high-quality development and monitoring of medical devices. **

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
  • Design Controls and Risk Management
  • Vendor qualification and auditing
  • Regulatory compliance (21 CFR Part 4, 820, ISO 13485, MDR)
  • Quality oversight of R&D projects

Nice-to-have

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

Key Requirements

  • Bachelor's degree in engineering or life science
  • 10+ years of experience in medical devices or combination products quality/engineering
  • 2+ years of people management experience
  • Experience in regulated environments
  • Experience with international and national regulations (21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDD/MDR)

Work Rights

Not specified

Tailored Resume

Cover Letter