Regional Lead Quality Engineer

Century Center

Waltham, MA, United States
Base: $143,000 - $169,000; bonus/equity: not speci...
On-site
21 cfr part 4 compliant quality system
Design control process
Fda / mdr regulations
CSL Behring is seeking a Regional Lead Quality Engineer for their Waltham, MA location, responsible for leading a regional team in ensuring the quality and compliance of medical devices and combination products. The ideal candidate will have extensive experience in quality assurance and regulatory compliance within the medical device industry

Job Summary

  • Responsible for leading a regional team comprised of Medical Device and Packaging QA Staff that supports design, development, manufacture, and regulatory approval of combination products.
  • 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 the emphasis on Design Control process.
  • Provides guidance and oversight to local staff and collaborates with multiple global functions and manufacturing sites to achieve primary objectives.

Matching Summary

Match Score: 85

CSL Behring is seeking a Regional Lead Quality Engineer for their Waltham, MA location, responsible for leading a regional team in ensuring the quality and compliance of medical devices and combination products. The ideal candidate will have extensive experience in quality assurance and regulatory compliance within the medical device industry.

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
  • combination products
  • medical device development

Nice-to-have

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

Key Requirements

  • Minimum 5 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

Work Rights

Not specified

Tailored Resume

Cover Letter