•Defined and developed Quality Plans for COVID essential projects.•Issue ECO's and MCO's to suppliers, following up through to implementation and closure.•Plan and execute validation and qualification of new projects via IQ, OQ, PQ format.•Sustained the quality standards by performing PQP for the parts in the production at NPI stage.

•Successfully lead supplier development program with cost savings: 400,000$.•Monitored customer returns (RMA's and FRU's) for failure trends to determine if any action is required to make hardware products more robust for customer use and hence reduce future defects by getting the process right in manufacturing.•Worked to ensure customer, process, and manufacturing quality by improving cosmetic specification procedures, streamlining repair/manufacturing processes, and helping organize the layout of the product lifecycle (PLC) (Agile PLM).•Closely work with the production shop floor, cleanroom Class 7, 8 to conduct the Root cause investigation and effectiveness.•Lead the reduction in Non-conformance material, RMA by being a part of material review broad (MRB) to conduct root cause investigation and corrective actions (CAPA).•Provided technical support to Quality inspectors, conduct training for the quality inspectors to incorporate various measurement methods in the inline process inspection requirements (IPIR).•Improved the Quality standards by collaborating with customers on the process control documents like a Process flow diagram, PFMEA, Control Plan.•Performed detailed root cause analysis and implemented process improvement on daily execution issues to meet customer's expectations; increase KPI's.•Reviewed and approved manufacturing work instructions and inspection methods as well as batch records to ensure conformance to requirements of ISO standards.•Successfully represented as a Quality Engineer in the ISO Audit: DQS-ISO 13485-Stage 2 Audit, IATF16949 transition Audit, ISO 9001 Audit.•Successfully conducted Continuous process improvement by monitoring, validating SPC data to meet CTQ, CTP, CTS characteristics required by the customer, (Statistical process control). Reduced the scrap rate by 20%.

•Ensured Product readiness/Low Volume Manufacturing (LVM), coordinating project schedule and requirements for the US and Asia.•Developed and implemented a new process for the Return Merchandise Authorization to prevent loss of devices.•Compiled data; prepared reports; distributed results, Updates weekly, monthly, and quarterly reports in Excel using advanced features (V-lookups, pivots, Macros, condition formulae), Research on BOM components with Agile PLM.•Evaluated the corrective action and preventative actions (CAPA) from the supplier and provided recommendations.

•Prepared MRB reports, Quality reports, distributed results, updated weekly, monthly, and quarterly reports to upper management.•Drive the QRQC meeting to follow up on the Corrective Actions.•Performed Gemba walks with Customer Quality Engineers to investigate the root cause and come up with preventive action.•Assisted in the PPAP project performed Gage R&R for doing MSA and prepared documents for submission.•Performed Strain Gauge test to check on strains caused at various locations by different testing equipment and machines on PCBAs and supported 8D to achieve the goals and objectives set by the customer.