Regional Lead Quality Engineer

CSL Behring

Waltham, MA, United States
$143,000 - $169,000 py
On-site
Combination product quality system
21 cfr part 4 compliance
Fda / mdr regulations
CSL Behring is seeking a Regional Lead Quality Engineer to oversee a team focused on ensuring compliance with quality systems for medical devices and combination products. The role involves guiding product development, vendor management, and maintaining quality assurance in alignment with regulatory standards

Job Summary

  • The Regional Lead Quality Engineer CP/MD is responsible for leading a regional team that supports design, development, manufacture, and regulatory approval of combination products.
  • This role is responsible for ensuring that 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.
  • The role assures product development and site level execution of the local CP/MD Quality System for combination products to govern quality related business processes throughout the entire combination product lifecycle, with emphasis on the new product development activities.

Matching Summary

Match Score: 85

CSL Behring is seeking a Regional Lead Quality Engineer to oversee a team focused on ensuring compliance with quality systems for medical devices and combination products. The role involves guiding product development, vendor management, and maintaining quality assurance in alignment with regulatory standards.

Salary

$143,000 - $169,000

Skills & Requirements

Must-have

  • combination product quality system
  • 21 CFR Part 4 compliance
  • FDA / MDR regulations
  • ISO and industry standards
  • Design Control process
  • risk analysis
  • statistical data analysis
  • sampling plan development
  • vendor management
  • Six Sigma problem solving

Nice-to-have

  • drug-delivery combination products experience
  • embedded software experience
  • mobile/web apps experience
  • connected health solutions experience

Key Requirements

  • Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline
  • Minimum 5 years of experience in quality, packaging, or manufacturing in medical devices or combination products
  • 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 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, relevant FDA guidance, relevant standards

Work Rights

Not specified

Tailored Resume

Cover Letter