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Chris
@ccamba
Medical Device Quality Manager
United States
English, Chinese
About me
I am a hands-on quality leader with over 20 years of experience, supporting Class II & III medical devices across R&D, manufacturing, supply chain, post-market surveillance and global distribution. I have proven expertise in building and maintaining ISO 13485-compliant QMS, remediation, and regulatory compliance throughout the product lifecycle. I specialize in helping start-ups and smaller companies achieve compliance.
My services include but are not limited to:
-SOPs, Forms and Work Instruction development
-FMEAs
-CAPAs
-Non-conformance reports
-KPIs for Management Review
Skills
Chris
Offline •
Average response time: 1 hour
See my services
Technical Writing
I will help you prepare audit ready quality management system documents
