Combination Products And Medical Devices Qa Lead

CSL SEQIRUS

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 Seqirus is seeking an Associate Director to lead the Quality Assurance for Combination Products and Medical Devices globally. The role focuses on developing and overseeing a quality system that meets regulatory standards throughout the product lifecycle, particularly emphasizing new product development

Job Summary

  • The role 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 entire product lifecycle.
  • This position 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 and equity as part of their total rewards package.

Matching Summary

Match Score: 85

CSL Seqirus is seeking an Associate Director to lead the Quality Assurance for Combination Products and Medical Devices globally. The role focuses on developing and overseeing a quality system that meets regulatory standards throughout the product lifecycle, particularly emphasizing new product development.

Salary

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

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
  • Risk management including FMEA techniques
  • Vendor qualification and audit program oversight
  • R&D project quality oversight for new products

Nice-to-have

  • Experience in pharmaceutical or biotech backgrounds
  • Strategic thinking for company-wide QMS integration
  • Cross-functional collaboration in matrix organizations
  • 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 quality or engineering
  • Minimum 2 years people management experience
  • Proficiency in English and MS Office applications

Work Rights

Not specified

Tailored Resume

Cover Letter