Supply Chain Management – SCM

Supply Chain Management – SCM

Supplier and CMO contract management: Agreements – QAA – QSV …
Experianced in Supplier & Contract Manufacturing Organization (CMO) assessments and audits regarding e.g. validation or qualification requirements for critical processes, within medical device production around Europe, the US and Asia.
Outsoursing of Manufacturing / Production Transfer, Project of any scale. Experianced working with Jabil e.g. Mexico.
Supplier evaluation and development in Europe for keeping track with Regulations (e.g. US-FDA 21CFR820: EU Regulation 2017/745 (MDR)) & Norms as e.g. ISO 9001, ISO 13485, IEC 60601 …
Technical / Compliance Due Dilligence

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