Regional Lead Quality Engineer

CSL Limited

Waltham, MA, United States
Base: $143,000 - $169,000; bonus/equity: incentive...
On-site
Combination product quality system
21 cfr part 4 compliance
Design control process
CSL Limited is seeking a Regional Lead Quality Engineer in Waltham, MA, to oversee quality assurance for combination products in compliance with regulatory standards. The role involves leading a team, ensuring adherence to quality systems throughout the product lifecycle, and collaborating with 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 assures product development and site level execution of the local CP/MD Quality System for combination products, with emphasis on new product development activities.
  • The role requires a Bachelor’s degree in a relevant discipline and a minimum of 5 years of experience in quality, packaging, or manufacturing within the medical devices or combination products field.

Matching Summary

Match Score: 85

CSL Limited is seeking a Regional Lead Quality Engineer in Waltham, MA, to oversee quality assurance for combination products in compliance with regulatory standards. The role involves leading a team, ensuring adherence to quality systems throughout the product lifecycle, and collaborating with global functions.

Salary

Base: $143,000 - $169,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Not specified

Skills & Requirements

Must-have

  • combination product quality system
  • 21 CFR Part 4 compliance
  • Design Control process
  • FDA / MDR regulations
  • ISO and industry standards
  • risk analysis
  • statistical data analysis

Nice-to-have

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

Key Requirements

  • Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline
  • Minimum 5 years of experience as a quality, packaging, engineer or manufacturing professional in medical devices or combination products field
  • 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

Work Rights

Not specified

Tailored Resume

Cover Letter