• Capital Projects management.• Process and equipment validation.• Creation and management of CR (change request).• Root Cause Analysis (RCA).• Events management, corrective actions and activities implementation through QA system (ETQ).• FAT (Factory Acceptance Test).• Creation of URS (User Requirements Specification).

Activities• Participation in daily meetings following an agenda to share updates about product conformance, process performance; reporting current issues, corrective actions, and everything related to the manufacturing environment. • Ensured that the Quality Metrics are posted and maintained up to date. • Reporting the assembly group when new defects are observed; quality alerts are posted to make personnel aware of the emergent new defect.• Performing risk assessments… Show more Activities• Participation in daily meetings following an agenda to share updates about product conformance, process performance; reporting current issues, corrective actions, and everything related to the manufacturing environment. • Ensured that the Quality Metrics are posted and maintained up to date. • Reporting the assembly group when new defects are observed; quality alerts are posted to make personnel aware of the emergent new defect.• Performing risk assessments related to process and dispositive (focus to patient).• Maintain environmentally controlled areas. Controls put in place include: high-efficiency air filtration systems, airborne particle counting, active air testing for microbial presence, microbial control in risk surfaces, gowning requirements, etc.• Receive, handle and control customer complaints thru web application (EtQ) to provide adequate response in timely manner. • Follow-up to corrective and preventive plans thoroughly to ensure the Quality system in continuously improved. • Follow-up to quality issues between plants• Development and execution of validation protocol for new equipment’s, new products thru regulated process (FDA & CFR 820).• Create and management change request• Sample plans.• Involved in validation meeting to review resources and time line. • Design and validation of test methods Show less

Activities• Creation and modification of document as forms, job aids and work instructions• Test Method Validation by R&R and Anova analysis.• Create and update PFMEA• Process capability, create chart for treading control process• Read and interpretation of drawing, review specification component• Knowledge in measurement systems and equipment to confirm the product meet specification• Reporting the manufacture personal the occurrence of defects and crate quality… Show more Activities• Creation and modification of document as forms, job aids and work instructions• Test Method Validation by R&R and Anova analysis.• Create and update PFMEA• Process capability, create chart for treading control process• Read and interpretation of drawing, review specification component• Knowledge in measurement systems and equipment to confirm the product meet specification• Reporting the manufacture personal the occurrence of defects and crate quality alerts• Containment Material• Research root cause analysis internal problems, customer complaints and corrective actions• Perform technical analysis and statistical tools for troubleshooting.• FAT (Factory Acceptance Test)• Critical to Quality Identification• Full layout dimensional analysis Show less