Engineer Quality

PREETHA MENON

* ******* *****, *** ***, Burlington, MA 01803 617-***-**** ***********@*****.*** ***************@*****.**.**

EDUCATION

Northeastern University Boston, MA

Master of Science in Engineering Management August 2012 – December 2014 Certification: LAI Lean Academy Course (Lean Concepts and Applications) Harvard University Cambridge, MA

Summer School: Course – Introduction to Decision and Operations Analysis June 2013 – August 2013 Harvard GSAS Business Club – Mini MBA Program June 2013 – July 2013 Maharashtra Institute of Technology Pune, India

Bachelor of Engineering in Mechanical Engineering August 2006 to June 2010 SKILLS

Software: Pro-E, Microsoft Office, AUTOCAD, SIMCA (Umetrics), JMP, Statistica Lean/Six sigma tools: 6S, Value Stream Mapping, FMEA, Poka-yoke, pull concept, Kaizen, Statistical Process Control techniques WORK EXPERIENCE

Fractyl Laboratories Inc. Lexington, MA

Process Quality Engineer June 2015 - Present

• Manage and support daily production tasks, firefighting and strive for seamless operation on the production floor.

• Create and execute process validation of equipment and fixtures used in test and assembly.

• Perform DOE to optimize processes, support continuous improvement idea generation and assist with implementation of 5S and Kaizen project planning, and the use of, and follow-up of Internal Corrective Actions (ICARs) for documented continuous improvement

• Lead Non-conforming Material Review Process and Corrective and Preventive Process.

• Create and update quality procedures, work instructions as well as other documentation required, improving quality, customer satisfaction and regulatory compliance. Participate in feasibility teams to evaluate product design at concept stage.

• Provide quality support in Incoming Quality Control inspection, Supplier Qualification, and MRB to support achieving world-class quality.

• Create Production and Quality Metrics.

Genzyme, a Sanofi Company

Framingham, MA

Data Analyst

January 2015 – June 2015

• Data acquisition from all applicable systems

• Data analysis as per requirements from team members to ensure that processed data is readily available for investigations

• Assist in validation of the software applications

• Forms Creation and database maintenance

Genzyme, a Sanofi Company

Framingham, MA

Graduate Co-op

January 2014 – July 2014

• Conducted Statistical Process Control Analysis to monitor the process, and detect outliers affecting the process using control charts, distributions, capability analysis using JMP software

• Performed Statistical Process Control Analysis for Periodic Product Review, conducted annually.

• Performed Multivariate Analysis using PLS models to determine the correlation between different parameters and compare the performance of different lots using score plots, T2 hotelling etc.

• Performed Non Linear Multivariate Analysis for drug products by plotting GIFI models (binning system) using SIMCA (Umetrics) Ace Engineers

Ahmednagar, India

Production Executive

July 2011 - July 2012

• Introduced and executed Lean management system in the company which included changing plant layout, introducing red tag area, implementing 5S, value stream mapping and restructuring the raw material store

• Supervised and assisted in development of new-machined castings for windmill transmission gearbox working on samples through PPAP

(Production Part Approval Process) batch and regular production.

• Worked on preparation of process flow, control plan, potential failure mode analysis (FMEA), measurement system analysis (MSA), process capability study (Cp,Cpk) and improvement of process capability

• Prepared schedules for daily production jobs and ensured delivery on time (DOT)

• Resided over daily production meetings, management review meetings and monitored team performance

• Introduced operator skill matrix and devised employee reward system to enhance team performance INA Bearings Pvt. Ltd. (Schaeffler Group)

Talegaon, India

Graduate Engineer Trainee (GET)

July 2010 - June 2011

• Assisted my manager in establishing and overlooking operations of the Project Management Department

• Ensured the implementation of PEP (Product Development Process in Schaeffler Group) in the company

• Worked on project management tools like project request, project plan, work breakdown structure, risk level assessment ensuring smooth implementation of projects

• Was a key team member on internal projects and also reviewed & tracked customer projects

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