CSL Behring is seeking a Regional Lead Quality Engineer to oversee a regional team responsible for ensuring the quality of medical devices and combination products throughout their lifecycle. The role involves compliance with regulatory standards and collaboration with global teams to support product development and manufacturing
Job Summary
Responsible for ensuring that new product development activities for all CSL combination product projects 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.
This role is involved in quality related activities throughout the entire product lifecycle from product concept, licensure, launch, and post market support.
Assure development and implementation of the quality system compliant with 21 CFR Part 4, MDR and other global requirements.
Matching Summary
Match Score: 85
CSL Behring is seeking a Regional Lead Quality Engineer to oversee a regional team responsible for ensuring the quality of medical devices and combination products throughout their lifecycle. The role involves compliance with regulatory standards and collaboration with global teams to support product development and manufacturing.
Salary
$143,000 - $169,000
Skills & Requirements
Must-have
Combination Products Quality System
21 CFR Part 4 compliant
Design Control process
ISO 13485
ISO 14971
EU MDR
Risk Analysis
Statistical Data Analysis
Nice-to-have
Six Sigma problem solving
Drug-delivery combination products experience
Connected health solutions 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