Combination Products And Medical Devices Qa Lead

cslbehring.ch

Base: $196,000-$232,000; bonus/equity: incentive c...
Fully remote
10 years medical device quality experience
Design controls implementation and oversight
Iso 13485 and fda 21 cfr part 820 knowledge
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 product lifecycle

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 product lifecycle.
  • This position requires developing and implementing Design Control processes that incorporate risk analysis and statistical data analysis for new product development activities.
  • CSL Behring offers a competitive base salary range of $196,000-$232,000 along with incentive compensation, equity, and a strong culture of inclusion and belonging.

Matching 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 product lifecycle.

Salary

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

Skills & Requirements

Must-have

  • 10 years medical device quality experience
  • Design Controls implementation and oversight
  • ISO 13485 and FDA 21 CFR Part 820 knowledge
  • Global Quality System development and management
  • Risk management including FMEA and ISO 14971

Nice-to-have

  • Experience with EU MDR and MDD regulations
  • Budgeting and financial management skills
  • Multi-site location management experience
  • Strategic planning for combination product portfolio
  • Cross-functional team leadership in matrix organization

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

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