• Responsible for providing technical assistance to Quality and Manufacturing groups.• Work with internal and external groups to ensure that proper definition of quality expectations and work on product and process quality.• Work cross functionally with various teams i.e., Engineering, Manufacturing, Regulatory and Customer support to execute various quality process and promote continuous improvement.• Support risk management activities by updating FMEA’s.• Responsible for Quality data reporting, data analysis, perform and monitor KPI’s for process improvement.• Lead containment activities, cross functional root cause analysis and CAPA.• Ensure effective resolution of customer quality issues & timely closure of SCARs.• Collaborated with key suppliers on qualification, process capability, quality issues, and process improvement.• Reviews Protocols, Process and Product Validations.• Lead Quality Support for the disposition of material via NCR’s.• Supplier 8D corrective action issuance and response review.• Supplier and customer engagement relating to manufacturing capabilities and design.• Review VMSI and supplier Quality Management Systems (QMS) for conformance to ISO 9001 and ISO 13485 standards.

• Investigate failures via root cause analysis techniques and methods, such as data analysis and physical inspection.• Identifying Production Issues, performing failure analysis, investigating root cause and executing corrective actions (CAPAs).• Assisting FA team during NPI by providing technical training to FA analyzers and creating Standard Operation Procedures (SOP) for accurate failure analysis through Design of Experiments (DOEs).• Promote Safety, 5S and Continuous Improvement culture using GEMBA.• Working on electronic components function failure resolution, process improvements and workmanship issues. • Creating detailed failure analysis reports depicting yield loss, root cause, corrective/preventive actions and control plan.• Assisted in improving the yield by implementing new station to reduce parts consumption.• Reporting technical issues, executed corrective actions and production KPIs to customer in weekly review meeting.• Creating immediate action proposals/plans for process and procedure changes to control critical to quality (CTQ) factors• Monitoring manufacturing quality performance metrics (KPIs) and communicating with multi-disciplinary teams for CAs.• Creating weekly production report to assign targets for engineering teams (ME, QE, IE and PT) based on failure trends • Generate and prepare FA Report to internal and external customers.• Tracking and analyzing data on daily, weekly and monthly basis to identify trends and area of analysis.