Quality Subject Matter Expert for the company’s Products
Driving CMOs Key Process Indicators to determine process effectiveness, identifying areas for improvement, best practices, scrap reduction and supplier quality improvement
Driving CMO to compliance to 21 CFR Part 820 and maintaining compliance to ISO 13485:2016 and EUR MDR
Supplier’s & CMO’s audits and following up on closure of any non-conformances
Supporting Supplier and CMO selection and approval process
Manager secondary and critical suppliers, and CMOs
Design transfer
Reviewer of process validation reports by external subcontract manufacturers
Associate Director deputy by ensuring the conformity of the devices before their release
Draft, review, and approve Quality Agreements