Regional Lead Quality Engineer

CSL Behring

Base: $143,000 - $169,000; bonus/equity: incentive...
Not specified (consider remote/hybrid based on industry norms).
5 years medical device quality experience
Design control process expertise
21 cfr part 4 and iso 13485 knowledge
CSL Behring is seeking a Regional Lead Quality Engineer to manage a team focused on quality assurance in the development of medical devices and combination products, ensuring compliance with regulatory standards. The ideal candidate will have significant experience in quality engineering within the medical device field and will provide guidance throughout the product lifecycle

Job Summary

  • The role ensures new product development activities follow a 21 CFR Part 4 compliant quality system in accordance with FDA and MDR regulations.
  • This position provides guidance to local staff and collaborates with global functions to govern quality-related business processes throughout the entire product lifecycle.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies for immunology and hematology conditions.

Matching Summary

Match Score: 85

CSL Behring is seeking a Regional Lead Quality Engineer to manage a team focused on quality assurance in the development of medical devices and combination products, ensuring compliance with regulatory standards. The ideal candidate will have significant experience in quality engineering within the medical device field and will provide guidance throughout the product lifecycle.

Salary

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

Skills & Requirements

Must-have

  • 5 years medical device quality experience
  • Design Control process expertise
  • 21 CFR Part 4 and ISO 13485 knowledge
  • Risk analysis and FMEA application
  • Vendor management and audit participation

Nice-to-have

  • Six Sigma problem solving skills
  • Experience with drug-delivery products
  • Knowledge of embedded software validation
  • Strong stakeholder influence abilities

Key Requirements

  • Bachelor's degree in engineering or life sciences
  • Minimum 5 years experience in medical devices
  • Practical experience in R&D Quality and design controls

Work Rights

Not specified

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