Regional Lead Quality Engineer

CSL Ltd

Waltham, MA, United States
Base: $143,000 - $169,000; bonus/equity: not speci...
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21 cfr part 4 compliant quality system
Design control process
Fda / mdr regulations
** CSL Ltd is seeking a Regional Lead Quality Engineer to oversee a team responsible for ensuring compliance with FDA and ISO regulations in the development of combination medical products. The role requires strong leadership in quality assurance processes throughout the product lifecycle, from design to post-market support, and emphasizes collaboration across global functions. **

Job Summary

  • The Regional Lead Quality Engineer CP/MD is responsible for leading a regional team that supports the design, development, manufacture, and regulatory approval of combination products.
  • This role ensures new product development activities follow a 21 CFR Part 4 compliant quality system in accordance with FDA / MDR regulations, ISO, and other industry standards with an emphasis on the Design Control process.
  • The role assures product development and site level execution of the local CP/MD Quality System for combination products throughout the entire lifecycle, with emphasis on new product development activities.

Matching Summary

Match Score: 75

** CSL Ltd is seeking a Regional Lead Quality Engineer to oversee a team responsible for ensuring compliance with FDA and ISO regulations in the development of combination medical products. The role requires strong leadership in quality assurance processes throughout the product lifecycle, from design to post-market support, and emphasizes collaboration across global functions. **

Salary

Base: $143,000 - $169,000; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 21 CFR Part 4 compliant quality system
  • Design Control process
  • FDA / MDR regulations
  • ISO and other industry standards
  • Risk analysis and statistical data analysis
  • Vendor management and audits

Nice-to-have

  • Six Sigma problem solving
  • Experience with connected health solutions
  • Experience with drug-delivery combination products

Key Requirements

  • Minimum 5 years of experience in medical devices or combination products
  • Bachelor's degree in mechanical or biomedical engineering, life sciences or relevant discipline
  • Minimum 2 years practical experience in medical devices R&D Quality

Work Rights

Not specified

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