The Regional Lead Quality Engineer at Centerforintegrationscience will lead a team overseeing quality assurance for medical devices and combination products, ensuring compliance with FDA, MDR, and ISO regulations throughout the product lifecycle. The role demands strong leadership, collaboration, and technical expertise in quality systems and design control processes
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 regional teams 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, employing 32,000 people across more than 100 countries.
Matching Summary
Match Score: 85
The Regional Lead Quality Engineer at Centerforintegrationscience will lead a team overseeing quality assurance for medical devices and combination products, ensuring compliance with FDA, MDR, and ISO regulations throughout the product lifecycle. The role demands strong leadership, collaboration, and technical expertise in quality systems and design control processes.
Salary
Base: $143,000 - $169,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Comprehensive well-being support detailed on company website
Skills & Requirements
Must-have
21 CFR Part 4 compliance expertise
Design Control process management
ISO 13485 and ISO 14971 knowledge
Vendor audit and management skills
Six Sigma problem solving techniques
Risk analysis and FMEA application
Nice-to-have
Experience with drug-delivery combination products
Knowledge of embedded software validation
Familiarity with mobile app connected health solutions
Strong stakeholder influence and assertiveness
Key Requirements
Bachelor's degree in mechanical or biomedical engineering
Minimum 5 years experience in medical devices or combination products
Minimum 2 years practical experience in R&D Quality