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CSL Behring is seeking two Packaging/Medical Device Quality Specialists to support the quality assurance of their combination products and medical devices. The role requires expertise in regulatory compliance, quality systems, and collaboration within global teams to ensure product quality throughout the lifecycle.
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Job Summary
The Combination Product and Medical Device and Packaging QA Associate will represent Quality in global teams involved in design, development, manufacture and regulatory approval of CSL combination products.
This role is responsible for ensuring that new product development activities for all CSL combination product projects follow a 21 CFR Part 4 compliant quality system.
The Medical Device and Packaging QA Staff (Advisor) will serve as a subject matter expert on medical device and combination product requirements in accordance with FDA / MDR regulations, ISO and other standards and industry best practices with the emphasis on Design Control process.
Matching Summary
Match Score: 75
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CSL Behring is seeking two Packaging/Medical Device Quality Specialists to support the quality assurance of their combination products and medical devices. The role requires expertise in regulatory compliance, quality systems, and collaboration within global teams to ensure product quality throughout the lifecycle.
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Salary
Base: $115,000 - $136,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Not specified
Skills & Requirements
Must-have
21 CFR Part 4 compliant quality system
Design Controls process
risk analysis
statistical data analysis
sampling plan development
FDA / MDR regulations
ISO 13485
ISO 14971
Nice-to-have
effective communication and collaboration
assertiveness
problem-solving skills
planning / organization skills
developing drug-delivery combination products
embedded software
connected health solutions
Key Requirements
Minimum 3 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: design controls, new product development life cycle, requirement specifications, risk management (including FMEA), validation/verification (V&V), usability / human factor studies, DHFs, design transfer