Packaging/medical Device Quality Specialist (x2)

CSL Behring

Base: $115,000 - $136,000; bonus/equity: incentive...
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Design control process expertise
Fda 21 cfr part 4 compliance
Iso 13485 and iso 14971 knowledge
** CSL Behring is seeking two Packaging/Medical Device Quality Specialists to ensure compliance with regulatory standards throughout the lifecycle of combination products and medical devices. The ideal candidates will bring experience in quality assurance, specifically within the medical device sector, and contribute to the design and development processes while collaborating with global teams. **

Job Summary

  • This role ensures new product development activities follow a 21 CFR Part 4 compliant quality system for CSL combination products.
  • The specialist serves as a subject matter expert on medical device requirements including FDA, EU MDR, and ISO standards throughout the product lifecycle.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies and advanced technologies.

Matching Summary

Match Score: 75

** CSL Behring is seeking two Packaging/Medical Device Quality Specialists to ensure compliance with regulatory standards throughout the lifecycle of combination products and medical devices. The ideal candidates will bring experience in quality assurance, specifically within the medical device sector, and contribute to the design and development processes 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 Control process expertise
  • FDA 21 CFR Part 4 compliance
  • ISO 13485 and ISO 14971 knowledge
  • Vendor management and audit experience
  • Root cause analysis and problem solving

Nice-to-have

  • Experience with drug-delivery combination products
  • Familiarity with embedded software and connected health
  • Strong communication and collaboration skills
  • Experience in pharmaceutical or biotech backgrounds

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
  • Working knowledge of 21 CFR 820 and EU MDR

Work Rights

Not specified

Tailored Resume

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