Combination Products And Medical Devices Qa Lead

CSL Behring

Base: $196,000-$232,000; bonus/equity: incentive c...
Fully remote
10 years medical device quality experience
Design controls implementation expertise
Iso 13485 and fda 21 cfr 820 knowledge
The Associate Director leads the Global CP/MD Quality System ensuring compliance with regulations like 21 CFR Part 4, 21 CFR Part 820, MDD/MDR, and ISO 13485 throughout the product lifecycle

Job Summary

  • The Associate Director leads the Global CP/MD Quality System ensuring compliance with regulations like 21 CFR Part 4, 21 CFR Part 820, MDD/MDR, and ISO 13485 throughout the product lifecycle.
  • This role is accountable for defining company strategy for combination products, managing R&D projects, and overseeing vendor qualifications and audits to ensure continuous quality oversight.
  • CSL Behring offers a competitive base salary range of $196,000-$232,000 along with incentive compensation, equity, and a strong culture focused on inclusion, belonging, and saving lives.

Matching Summary

The Associate Director leads the Global CP/MD Quality System ensuring compliance with regulations like 21 CFR Part 4, 21 CFR Part 820, MDD/MDR, and ISO 13485 throughout the product lifecycle.

Salary

Base: $196,000-$232,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Not specified

Skills & Requirements

Must-have

  • 10 years medical device quality experience
  • Design Controls implementation expertise
  • ISO 13485 and FDA 21 CFR 820 knowledge
  • Global Quality System leadership
  • Risk management and FMEA application
  • Vendor qualification and audit management

Nice-to-have

  • Experience in pharmaceutical or biotech sectors
  • Multi-site location management capability
  • Budgeting and financial management skills
  • Strategic planning for connected health
  • Cross-functional team collaboration

Key Requirements

  • Bachelor's degree in engineering or life science
  • Minimum 10 years industry experience
  • Minimum 2 years people management experience
  • Proficiency in English and MS Office

Work Rights

Not specified

Tailored Resume

Cover Letter