Base: $115,000 - $136,000; bonus/equity: not speci...
On-site
21 cfr part 4 compliant quality system
Medical device and combination product regulations
Design controls process
CSL Seqirus is seeking a Packaging/Medical Device Quality Specialist in Waltham, MA, to ensure compliance with quality systems for combination products and medical devices. The role focuses on maintaining FDA and global regulatory standards throughout the product lifecycle, collaborating with various teams, and serving as a quality authority on medical device requirements
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.
Serve as a subject matter expert on medical device and combination product requirements in accordance with FDA / MDR regulations, ISO and other standards.
Collaborate with multiple global functions and manufacturing sites throughout the entire product lifecycle.
Matching Summary
Match Score: 85
CSL Seqirus is seeking a Packaging/Medical Device Quality Specialist in Waltham, MA, to ensure compliance with quality systems for combination products and medical devices. The role focuses on maintaining FDA and global regulatory standards throughout the product lifecycle, collaborating with various teams, and serving as a quality authority on medical device requirements.
Salary
Base: $115,000 - $136,000; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
21 CFR Part 4 compliant quality system
Medical device and combination product regulations
Design Controls process
Risk analysis and statistical data analysis
Vendor management and audits
Nice-to-have
Experience with drug-delivery combination products
Experience with connected health solutions
Proactive problem-solving and assertiveness
Key Requirements
Minimum 3 years of experience in medical devices or combination products
Minimum 2 years practical experience in medical devices R&D Quality
Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline