c
ccamba

Chris

@ccamba

Medical Device Quality Manager

États-Unis
Anglais, Chinois
Certaines informations sont présentées en anglais.
À propos de moi
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... Plus d’infos

Compétences

c
ccamba
Chris
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Voir mes services

Rédaction technique
I will help you prepare audit ready quality management system documents

Portfolio