Packaging/medical Device Quality Specialist (x2)

cslbehring.de

Base: $115,000 - $136,000; bonus/equity: incentive...
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21 cfr part 4 compliant quality system
Design controls process
Risk analysis and statistical data analysis
** CSL Behring is seeking two Packaging/Medical Device Quality Specialists to join their Quality for Combination Products and Medical Devices team. The role entails ensuring compliance with regulatory standards throughout the product lifecycle, requiring expertise in medical device quality systems and collaboration with global teams. **

Job Summary

  • The Combination Product and Medical Device and Packaging QA Associate will represent Quality in global teams involved in design, development, manufacture and regulatory approval of CSL combination products.
  • This role is responsible for ensuring that new product development activities for all CSL combination product projects follow a 21 CFR Part 4 compliant quality system.
  • The Medical Device and Packaging QA Staff (Advisor) will serve as a subject matter expert on medical device and combination product requirements in accordance with FDA / MDR regulations, ISO and other standards and industry best practices with the emphasis on Design Control process.

Matching Summary

Match Score: 75

** CSL Behring is seeking two Packaging/Medical Device Quality Specialists to join their Quality for Combination Products and Medical Devices team. The role entails ensuring compliance with regulatory standards throughout the product lifecycle, requiring expertise in medical device quality systems and collaboration with global teams. **

Salary

Base: $115,000 - $136,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Not specified

Skills & Requirements

Must-have

  • 21 CFR Part 4 compliant quality system
  • Design Controls process
  • risk analysis and statistical data analysis
  • medical device and combination product regulations
  • ISO 13485 and ISO 14971

Nice-to-have

  • experience with drug-delivery combination products
  • experience with embedded software
  • connected health solutions

Key Requirements

  • Minimum 3 years experience
  • Bachelor's degree in relevant discipline
  • Minimum 2 years practical experience in medical devices R&D Quality

Work Rights

Not specified

Tailored Resume

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