Supplier Quality Engineer
September 2012 — Present
Supplier Quality & Compliance Engineer for Flextronics Global/Corporate Quality
• Planned and performed corporate & supplier audits per audit schedule which included product, process, surveillance, ad-hoc and maintenance audits.
• Prepared audit reports and other report’s / summary of performances, trends and schedule associated with supplier quality management.
• Provided support to identify and resolve issues associated with purchased parts, materials and manufacturing methods for Flextronics Global. Sites ranging from Israel to Guadalajara, Mexico.
• Worked with the auditee’s (within the global Flextronics) /suppliers to resolve compliance issues, provide recommendations, review and monitor corrective and preventive actions, and conduct a test run on the effectiveness of the QMS system.
• Worked with customer/suppliers engineering drawings, specifications, & schematics, diagrams, to perform tasks.
• Worked with sites and suppliers on improvement projects.
• Performed reviews of site High Reliability Solutions (HRS) systems compliance.
• Assessed HRS sites to Site Maturity Tracker (SMT) with actual compliance status.
• Aid in the creation of gap analysis to any new/changed regulations and the Flex Medical QMS and site compliance.
• Provided internal communication regarding compliance issues.
• Worked closely with FDA(Food & Drug Administration) to understand and comply to the requirement of the FDA QSR Part 820
• Certified Lead Auditor for ISO9001:2008 ISO/TS16949:2009 & ISO 13485:2003
• Travelled frequently to prepare sites that will be going through FDA audits & inspection.
• Performed audits on various suppliers of various commodities with the concept of “jack of all traits and master of none”
• Supported Flextronics to perform site validation,process validation and product validation when there is a new site to be set up or a new project to be commenced.