Mechanical Engineering Quality

Anand Rathnam

E-mail:********@**.*** Mobile: +1-832-***-****

OBJECTIVE: Mechanical Engineer with work experience in Product Quality Control, Testing, Validation & Quality Assurance is seeking the position of Associate Quality Engineer.

EDUCATION: Master of Science, Mechanical Engineering 2016-2017 University of Houston, TX.

Bachelor’s Degree, Mechanical Engineering 2009-2013 Anna University, Chennai.

WORK: Signature Systems Group, Los Angeles, CA May 2017 - August 2017 Mechanical Engineering Intern, Quality Control

• Precise documentation of SOP to design, manufacture, packaging parts of specialty floor to the required engineering specifications adhering to GMP system to help the new resources move up the learning curve easily.

• Developed CAPA report to improve the process, eliminate the nonconformities by evaluating the process/product based on complaints & inputs.

• Utilized various Quality Control like Scatter diagram, Pareto Chart to understand the process parameter co-relation affecting the product finish.

• Developed Process flow diagrams, inspection procedures, flow charts using MS Visio and control plans for sustained quality control.

• Managed the reports on tooling capacity, life and executed systematic troubleshooting of equipment.

• Analyzed the engineering requirements and used calipers, gauges and scales to calibrate the equipment and tooling for precise machining.

• Tracked Quality metrics of raw material supplies and finished products using Statistical process control charts using Minitab.

• Investigated problems by conducting PFMEA-Process Failure Mode Effective Analysis, 8 D methodology, Root Cause Analysis and Lean manufacturing tools to document the current knowledge and actions about the risks of failures.

• Developed Process Improvement Solutions, Kaizen and Continuous Improvement of ISO 9001 quality system for continual growth. Amazon Development Centre, Chennai 2015-2016

Senior Device Associate – Test Process Design and Process Validation.

• Designed unique and customer perspective usability test experiments and process for laboratory troubleshooting of products to identify defects.

• Experienced in development and execution of process validation protocols including IQ, OQ, PQ for process equipment.

• Performed Statistical Process Control for process capability, trend analysis to monitor the quality of the products and capture the deviations.

• Investigated design changes and failures, product complaints, and non-conformance. Reported findings, initiated review and developed corrective and preventive action maintenance document. Ensured compliance with the Quality Management System.

• Evaluation and Analysis of legacy devices using design history files and requirements for validation process.

• Performed DOE, Regression Testing analysis to identify the influencing process parameter in the test results.

• With complete understanding of the requirements acted as a subject matter expert during New Product Development cycle.

• Conducted Audits to determine the effectiveness of QMS objectives and Implementation of recommended procedures.

• Conducted FMEA for product development and Risk Mitigation. Performed Root Cause Analysis by categorizing various factors for Investigation.

• Handled Risk Management by performing Risk- Analysis, Evaluation, Risk Control and Residual Risk Evaluation.

• Ensured compliance with the Quality System requirements by developing, implementing and executing processes. Cognizant Technology Solutions, Chennai 2013-2015

Quality Assurance Engineer – Testing, Validation and Project Management

• Involved in Validation of Manufacturing software application employed in the production environment by developing and executing protocols.

• Handled multiple projects by planning, scheduling, allocating and tracking up to closure by working under strict deadlines.

• Conducted Internal audits and triggered RCA for issues by referring to the business requirements in the product realization of QMS to address the quality gap. Developed fault tree analysis for high priority defects as a Risk Mitigation.

• Worked in Defect Management, Risk Assessment and development of CAPA coordinating with the business analyst.

• Meticulous documentation of testing results, defects, assignment, test data, and requirements. Maintained and updated the documents using revision control. Generated reports using VBA in excel by writing macros.

• Proactive in test case design adhering to ISO standards, execution, defect management. Skilled in reporting and gathering test metrics.

• Communicated updates in Team meetings on project status, quality assurance activities, quality metrics and KPI.

• Collaborated with cross functional teams and acted as a liaison between quality assurance team and rest of the stake holders. SKILL SETS: CAPA Administration Root Cause Analysis (RCA) MS Office MS Visio Minitab Validation Protocols (IQ, OQ, PQ) Test Method Validation Fault Tree Analysis (FTA) DFMEA and PFMEA VBA - Excel Solid Works Process Qualification and Verification Statistical Process Controls (SPC) Geometric Dimensioning & Tolerance (GD&T) Six-Sigma, Lean & Kaizen Design of Experiments.

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