Packaging/medical Device Quality Specialist (x2)

CSL Behring

Base: $115,000 - $136,000; bonus/equity: incentive...
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Design controls process expertise
Risk analysis and fmea application
Validation and verification experience
** CSL Behring is seeking two Packaging/Medical Device Quality Specialists to join their Quality for Combination Products and Medical Devices team. The role involves ensuring quality compliance in the development and manufacturing of combination products, adhering to regulatory requirements while collaborating with global teams. **

Job Summary

  • This role ensures new product development activities follow a 21 CFR Part 4 compliant quality system for combination products.
  • The position requires serving as a subject matter expert on medical device requirements in accordance with FDA and EU MDR regulations.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies.

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 involves ensuring quality compliance in the development and manufacturing of combination products, adhering to regulatory requirements while collaborating with global teams. **

Salary

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

Skills & Requirements

Must-have

  • Design controls process expertise
  • Risk analysis and FMEA application
  • Validation and verification experience
  • Vendor management and audit support
  • Root cause analysis skills

Nice-to-have

  • Experience with drug-delivery products
  • Knowledge of embedded software systems
  • Connected health solutions background
  • Statistical data analysis proficiency

Key Requirements

  • Bachelor's degree in engineering or life sciences
  • Minimum 3 years experience in medical devices
  • Minimum 2 years practical R&D Quality experience

Work Rights

Not specified

Tailored Resume

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