Packaging/medical Device Quality Specialist (x2)

CSL Behring

Base: $115,000 - $136,000; bonus/equity: incentive...
Not specified (assumed hybrid).
Design controls process implementation
Fda 21 cfr part 4 compliance
Eu mdr and iso 13485 knowledge
CSL Behring is seeking two Packaging/Medical Device Quality Specialists to join their Quality for Combination Products and Medical Devices department. The role involves ensuring compliance with global regulatory requirements throughout the product lifecycle and requires a strong background in quality assurance for medical devices

Job Summary

  • The role ensures new product development activities follow a 21 CFR Part 4 compliant quality system throughout the entire product lifecycle.
  • Candidates will serve as subject matter experts on medical device requirements in accordance with FDA, EU MDR, and ISO standards.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies and a culture of inclusion.

Matching Summary

Match Score: 85

CSL Behring is seeking two Packaging/Medical Device Quality Specialists to join their Quality for Combination Products and Medical Devices department. The role involves ensuring compliance with global regulatory requirements throughout the product lifecycle and requires a strong background in quality assurance for medical devices.

Salary

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

Skills & Requirements

Must-have

  • Design controls process implementation
  • FDA 21 CFR Part 4 compliance
  • EU MDR and ISO 13485 knowledge
  • Risk analysis and FMEA application
  • Vendor management and audit support

Nice-to-have

  • Experience with drug-delivery combination products
  • Knowledge of embedded software and connected health
  • Strong problem-solving and assertiveness skills
  • Effective global team collaboration abilities

Key Requirements

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

Work Rights

Not specified

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