Packaging/medical Device Quality Specialist (x2)

CSL Ltd

Base: $115,000 - $136,000; bonus/equity: incentive...
Not specified
21 cfr part 4 compliant quality system
Design controls process
Risk analysis
CSL Ltd 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 for medical device combination products

Job Summary

  • 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.
  • The Medical Device and Packaging QA Associate will collaborate with the multiple global functions and manufacturing sites.

Matching Summary

Match Score: 85

CSL Ltd 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 for medical device combination products.

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
  • statistical data analysis
  • sampling plan development
  • vendor management activities
  • root cause analysis

Nice-to-have

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

Key Requirements

  • minimum 3 years of experience
  • Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline
  • minimum 2 years practical experience in medical devices R&D Quality: design controls, new product development life cycle, requirement specifications, risk management (including FMEA), validation/verification (V&V), usability / human factor studies, DHFs, design transfer
  • working knowledge of medical device and combination product regulations and requirements, at a minimum, 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, relevant FDA guidance, relevant standards and their application in a compliant QMS

Work Rights

Not specified

Tailored Resume

Cover Letter