Combination Products And Medical Devices Qa Lead

CSL Behring

Base: $196,000-$232,000; bonus/equity: incentive c...
Fully remote
Global cp/md quality system development
Design controls compliance with 21 cfr part 820
Iso 13485 and eu mdr regulatory knowledge
CSL Behring is seeking an Associate Director for their Combination Products and Medical Devices Quality Assurance department, responsible for leading global quality systems and ensuring compliance throughout the product lifecycle. The ideal candidate will have extensive experience in medical devices or combination products, with a strong focus on regulatory standards and quality management

Job Summary

  • The Associate Director is responsible for leading the Global CP/MD Quality System to ensure compliance with regulations like 21 CFR Part 4 and ISO 13485 throughout the product lifecycle.
  • This role requires extensive practical experience in medical device R&D, specifically managing design controls, risk analysis, and validation activities for new product development.
  • 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 and belonging.

Matching Summary

Match Score: 85

CSL Behring is seeking an Associate Director for their Combination Products and Medical Devices Quality Assurance department, responsible for leading global quality systems and ensuring compliance throughout the product lifecycle. The ideal candidate will have extensive experience in medical devices or combination products, with a strong focus on regulatory standards and quality management.

Salary

Base: $196,000-$232,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Comprehensive health and well-being support mentioned

Skills & Requirements

Must-have

  • Global CP/MD Quality System development
  • Design Controls compliance with 21 CFR Part 820
  • ISO 13485 and EU MDR regulatory knowledge
  • Vendor qualification and audit program management
  • Risk management including FMEA techniques
  • New product development lifecycle oversight

Nice-to-have

  • Experience in pharmaceutical or biotech backgrounds
  • Strategic thinking for global quality vision
  • Cross-functional collaboration skills
  • Budgeting and financial management experience
  • Multi-site location management experience

Key Requirements

  • Bachelor's degree in engineering or life science
  • Minimum 10 years in medical device QA or engineering
  • Minimum 2 years people management experience
  • Proficiency in FDA, MDR, and ISO standards
  • Experience managing multi-site locations preferred

Work Rights

Not specified

Tailored Resume

Cover Letter