Quality Supply Chain

Diksha Chechi

** *** ****** *, *** Jose, CA-***** 213-***-**** ******.******@****.***

EDUCATION

Masters in Industrial & Systems Engineering

San Jose State University, California Aug ‘15 - May ‘17 Courses: Quality Assurance & Reliability, Managing the Lean Enterprise, Leading the Six Sigma Improvement Project, Systems Engineering, Financial Methods for Engineers, Logistics for Supply Chain, Probability and Statistics, Operations Planning & Control, Principles of Engineering Management Bachelors in Biomedical Engineering

Maharishi Dayanand University, Haryana, India Aug ‘08 - July ‘12 SKILLS AND CERTIFICATION

Ø Tools: Minitab, FMEA, ANOVA, JIT, Six Sigma, Human Factors, Lean, Livelink, SPC, SharePoint, 8D, Kaizen, FAI, Kano, 5s, JIT, KPIs

Ø Technical Skills: Microsoft Office (Excel, Word, PowerPoint, Outlook), ISO 13485:2003, SAP, Quality Management Systems (QMS), 21 CFR Part 820, ISO 9001, Non-Conformance report (NCR) systems, Quality System Regulation, Kanban, CAPA, GCPs, GLPs, GMPs, FDA Regulations Ø Certification: Six Sigma Green Belt

EMPLOYMENT SUMMARY

Supplier Quality Intern, Varian Medical Systems, California Aug ‘16 - Dec ’16 Ø Managed development of supplied product inspection procedures and first article requirements. Ø Maintained the Approved Supplier List (ASL) & schedule for the suppliers. Ø Proactively communicated quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests (SCAR) and technical discussions. Ø Prepared plans and reports of internal audits of facility quality systems. Ø Contributed and participated in supplier management activities such as supplier risk assessments, supplier performance reviews and score carding.

Ø Supported internal teams for proper resolution of parts attributed to poor supplier quality, including CAPA review and closure.

Ø Initiated non-conformance reports as per the established requirements. Ø Coordinated with internal teams to implement changes as per the QSD requirements. Ø Supported the implementation of changes and upgraded to systems, procedures, and processes to improve product quality.

Ø Managed Supplier Change Requests (PCRs) to ensure supplier’s qualification as per Quality system requirements which includes new supplier process validation and location transfers. Ø Collaborated on supplier verification and validation documentation. Ø Evaluated test data by utilizing statistical evaluation techniques. Supply Chain Quality Intern, NewGen Surgical Inc., California May ‘16 - Aug ‘16 Ø Managed Procurement activities for China, Taiwan, Mexico & India supplier base. Ø Supported the quality assurance plans in order to meet FDA GMP/GLP, ISO 13485:2003, ISO 9001:2008 requirements.

Ø Managed Quality guidance on risk management documents and identifying gaps and risk mitigation to the FMEA (Failure mode effects analysis).

Ø Supported standard operating procedures and other established specifications to maintain compliance with applicable regulations.

Ø Analyzed data metrics for continuous improvement effort for the processes, documentation and inspection methods.

Ø Maintained and assisted the implementation of Supply chain policies, procedures, techniques & systems to achieve departmental goals.

Ø Evaluated protocols, SOP’s, inspection forms for compliance with the regulatory standards. Ø Monitored Supplier performance on the basis of their quality, cost & reliability. Ø Contributed to the CAPAs implementation and product launching activities. Operations Specialist, Metro Hospital & Heart Institute, India July ‘12 - Aug ‘14 Ø Managed and Updated inventory to ensure compliance while following appropriate policies. Ø Developed RFX, evaluated vendor responses, and qualify and recommended finalist vendor. Ø Performed statistical analysis to improve operational excellence and to meet the customers demand.

Ø Implemented appropriate and efficient preventive and corrective actions to avoid downtime. Ø Negotiated pricing with vendors leading to cost reduction of 30% while maintaining quality services.

Ø Analyzed large metric data through graphs and control charts for efficient flow of work. Ø Implemented lean techniques 5s, DMAIC, MUDA to eliminate waste and streamline the tooling process.

Ø Developed scorecards for suppliers for their quality performance, cost & service performance, supplier capability and monitoring low performance suppliers. Ø Streamlined procurement requests by coordinating with local vendors, and reducing the cost of spare parts of medical devices.

Ø Accountable for complete machine installation including Requirement Analysis, Pre- Installation check up, Installation and Post-Installation maintenance for Bio-Medical Equipment. Ø Developed reports, Gantt charts, procedures and templates that supports tactical and strategic execution.

Ø Developed communication mechanisms for sharing transparent and impactful key performance indicators (KPI’s) by identifying the improvement areas & recommended necessary changes. GRADUATE PROJECTS

Application of Six Sigma Principles

Ø Reduced wait time at a Grocery store using DMAIC and Six Sigma principles. Ø Average waiting time reduced efficiently from 48.16 minutes to 36.10 minutes resulting in 17.06 % of overall improvement. This improved the service quality and in turn increased customer satisfaction. Ø Tools used: Excel for analysis, SIPOC, MUDA, CTQ, 5s, Value stream mapping, Root cause analysis, Pareto analysis, Kano, Ishikawa, Voice of the customer (VOC), FMEA, why-why diagram, Kaizen. Operations planning & control

Ø Executed the entire operations planning process including but not limited to forecasting, scheduling and capacity planning.

Ø Established a formal method for forecasting the demand, planning the production based on bill of material and capacity, and scheduling the production of the different product types. Ø Developed most cost-effective strategy for production and scheduling.

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