CSL Behring is seeking a Regional Lead Quality Engineer to oversee a team supporting the development and regulatory approval of combination products and medical devices. The role emphasizes compliance with FDA and EU regulations, guiding teams through the product lifecycle while ensuring quality standards are met
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 Behring is seeking a Regional Lead Quality Engineer to oversee a team supporting the development and regulatory approval of combination products and medical devices. The role emphasizes compliance with FDA and EU regulations, guiding teams through the product lifecycle while ensuring quality standards are met.
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
FDA / MDR regulations
ISO standards
Design Control process
Risk analysis
Statistical data analysis
Nice-to-have
Six Sigma problem solving
Connected health solutions
Embedded software experience
Key Requirements
Minimum 5 years 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