•CAPA, NCR, supplier and customer issues•Clean Room class 8 based on ISO 14644-1•Develop, review and maintain Design History Records (DHR) for products.•Status of Conforming and Nonconforming product.

• Part of the value stream team for one product, and all related to quality for this product, process and materials.• QE responsible for CAPAs, NCMRs, FMEAs, Control plan, Statistical analysis, etc.• Monitoring clean room ISO 8 class based on ISO 14644-1 cleanroom standards.• Analysis of monitoring results for clean room.• Part of the problem solving team for internal and external customer complaints.• Active participant in ISO audits.• Control process implementation on critical areas. • Support in transfers and validations process.• Supervisor of incoming inspection conformed by 1 technician and 2 inspectors.• In site supplier audits, schedules, reports and following up findings.• Control of non conforming material, MRB meetings, following SCARs.• Reduce inventory 30% of non conforming material on quarantine area. • Monitoring Supplier performance.• FAI and inspections plans for raw material.• Programmer responsible on the Ram Optical for inspection improvement.

• Kaizen and Lean Manufacturing Projects.• ISO/FDA/Customer audits.• Transfers and Validations process.• Clean Room Class 7 based on ISO14644-1 • CAPAs, NCMRs, FMEAs, Control plan, Statistical analysis, etc.• Molding and Machinery areas.• Supplier audits, Approval, Qualification and Certification program

• NCMR’s, Internal and Process Audits, SPC• Premier Quality System (TPS) and ISO9001:2000 certification.• Document Control.• Process change and new process validation.• Measurement equipment.• Customer Complains.