Packaging/medical Device Quality Specialist (x2)

CSL

Waltham, MA, United States
Base: $115,000 - $136,000; bonus/equity: incentive...
On-site
21 cfr part 4 compliant quality system
Design controls process
Risk analysis
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

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.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives.

Matching 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.

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
  • vendor management activities
  • root cause analysis

Nice-to-have

  • drug-delivery combination products experience
  • embedded software experience
  • mobile/web apps 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
  • 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR knowledge
  • Minimum 2 years practical experience in medical devices R&D Quality

Work Rights

Not specified

Tailored Resume

Cover Letter