Summary: John has been an ASQ-certified Quality Engineer and ASQ-certified Quality Auditor and a Philips-Global-certified Lead Auditor with a strong experience within medical device, pharmaceutical and contract packaging companies, while following FDA drug Good Manufacturing Practices, FDA medical device Quality System Regulation, ISO 9001 and ISO 13485 environments. He has a solid understanding with QSR supplier control systems, regulatory compliance and supplier issue resolutions. In his work experience, he, assured conformance with the FDA Quality System Regulation (QSR) for medical devices, regarding supplier quality systems, including developed and implemented supplier surveys, supplier agreements, supplier quality agreements, issuing and closing out SCARs, tracking mechanisms for supplier quality systems and performance. Furthermore, he was responsible for conducting supplier and internal quality audits, establishing and maintaining supplier quality files, registering products and maintaining registrations of products worldwide, implementing sampling and inspection procedures and SPC, conducting process capability studies plus validations, facilitating CAPAs plus providing technical support to OEM customers and Sales.

Highlights:

• Supplier Quality Systems
• Internal Quality Auditing
• Supplier Quality Auditing
• Complaint handling
• MRB actions
• CAPA
• ISO
• Audit
• Compliance
• Quality Assurance