Combination product and medical device quality system
21 cfr part 4 compliant quality system
Design control process
CSL Behring is seeking two Packaging/Medical Device Quality Specialists in Waltham, MA, to ensure compliance with quality systems during the development of combination products and medical devices. The role involves collaboration with global teams and requires expertise in FDA, MDR regulations, and design control processes
Job Summary
The role is responsible for ensuring new product development activities for CSL combination product projects follow a 21 CFR Part 4 compliant quality system.
This role is involved in quality related activities throughout the entire product lifecycle from product concept through industrialization and post market support.
The Medical Device and Packaging QA Associate will collaborate with multiple global functions and manufacturing sites.
Matching Summary
Match Score: 85
CSL Behring is seeking two Packaging/Medical Device Quality Specialists in Waltham, MA, to ensure compliance with quality systems during the development of combination products and medical devices. The role involves collaboration with global teams and requires expertise in FDA, MDR regulations, and design control processes.
Salary
Base: $115,000 - $136,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Not specified
Skills & Requirements
Must-have
Combination Product and Medical Device Quality System
21 CFR Part 4 compliant quality system
Design Control process
FDA / MDR regulations
ISO and other standards
Risk analysis and statistical data analysis
Vendor management and audits
Nice-to-have
Experience with connected health solutions
Experience with embedded software
Experience with mobile/web apps
Key Requirements
Minimum 3 years of 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
Working knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR