c
ccamba

Chris

@ccamba

Medical Device Quality Manager

Stati Uniti
Inglese, Cinese
Alcune informazioni sono riportate in lingua inglese.
Chi sono
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... Continua a leggere

Competenze

c
ccamba
Chris
offline • 
Tempo di risposta medio: 1 ora

Consulta i miei servizi

Scrittura tecnica
I will help you prepare audit ready quality management system documents

Portfolio