Packaging/medical Device Quality Specialist (x2)

CSL Behring

Waltham, MA, United States
Base: $115,000 - $136,000; bonus/equity: may inclu...
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21 cfr part 4 compliant quality system
Design control process
Medical device and combination product regulations
** CSL Behring is seeking two Packaging/Medical Device Quality Specialists to join their Quality for Combination Products and Medical Devices team in Waltham, MA. The role focuses on ensuring compliance with regulatory standards throughout the product lifecycle while collaborating with global teams on the development of innovative medical devices. **

Job Summary

  • The 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.
  • This role is involved in quality related activities throughout the entire product lifecycle from product concept through industrialization and post market support.
  • The Medical Device and Packaging QA Staff (Advisor) should have a working knowledge of the 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.

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 in Waltham, MA. The role focuses on ensuring compliance with regulatory standards throughout the product lifecycle while collaborating with global teams on the development of innovative medical devices. **

Salary

Base: $115,000 - $136,000; Bonus/Equity: May include incentive compensation and equity; Benefits: Not specified

Skills & Requirements

Must-have

  • 21 CFR Part 4 compliant quality system
  • Design Control process
  • Medical device and combination product regulations
  • Risk analysis and management
  • Vendor management and audits

Nice-to-have

  • Experience with connected health solutions
  • Assertiveness and problem-solving skills
  • Planning and organization skills

Key Requirements

  • Bachelor's degree in mechanical or biomedical engineering, life sciences or relevant discipline
  • Minimum 3 years of experience in medical devices or combination products quality, packaging, engineering, or manufacturing
  • 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

Work Rights

Not specified

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