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Quality Engineer

Location:
Kalamazoo, Michigan, United States
Posted:
November 02, 2018

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Resume:

VISHAL S BANE

Cell No:316-***-**** ac7lbh@r.postjobfree.com

Experience Summary

4+ years of experience in field of Manufacturing and Quality. Worked closely with Quality and Design department to carry various tests on Industrial mixers.

Implemented lean techniques such as Kaizen, 5S and just in time and reduced wastes. Worked closely with suppliers to reduce raw material cost by 4%. Experienced in navigating teams through changing Business environment. Good GMP knowledge.

Worked on AutoCAD and Catia V5 to design Industrial mixers parts and delivered on time.

Knowledge of IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), CAPA, TMV (Test Method Validation), etc.

Experience with Designing 3D and 2D

Area of Expertise: Lean Manufacturing, Six Sigma, APQP, Supply Chain, Just in Time, 5S and Kaizen.

Working knowledge of UG Nx-4, Auto CAD, Catia V5, Solidworks, Ansys, Statgraphics, Design Expert.

Certification

Certified Six Sigma Green Belt (ASQ)

Lean Systems (Wichita State University)

Diploma in Product Design and Analysis (Cadd Center)

Education

Master of Science Industrial Engineering Aug 2015-May2017

Wichita State University, Wichita, KS GPA: 3.75

Bachelor of Engineering Mechanical Engineering Aug 2010-Jun 2014

Mumbai University, Mumbai, INDIA GPA: 3.50

Work Experience

Zimmer Biomet (Contract Modis E&T) June2018 - Present

Establishing process methods, which meet performance and quality requirements.

Establishing preliminary bill of materials and routers.

Sorting through options choosing the most appropriate processes and machining methods.

Negotiating target completion dates with appropriate personnel from other departments.

Developing project plans and schedules for work activities

Experienced in control procedures, such as the Engineering Change Notification (ECN) and Deviation process, Zimmer Engineering Specifications (ZESs), and Zimmer Laboratory Procedures (ZLPs).

Reviewing Engineering drawings and approving for Unique Device identification (UDI)

Conducting Gage R&R study using Minitab

Handling project assignments of medium scope and complexity and able to prioritize and complete work in a timely manner.

Demonstrating good problem solving skills with quality and statistical tools.

Working effectively within a team and cross functionally to expedite completion of critical project tasks.

Medtronic Neurovascular (Contract L&T) June 2017- May 2018

Coordinated and supervised the quality incoming, in-process and final inspection activities

Working with FDA, cGMP, ISO:13485 Medical device Quality Management Systems

Identified and developed qualification/validation plans for manufacturing processes of different medical devices

Executed validation activities (IQ/OQ/PQ) on Lasers, UV Cure, Ultrasonic Cleaner, etc. and subsequently trained manufacturing operators for validation activities in accordance

Established a strong working relationship with all levels of operations in order to appropriately monitor and analyze in-process inspection, process control activity, and waste and reject rates, PM compliance, environmental control and customer complaint levels in order to take a lead role in identifying and documenting continuous improvement projects.

Performed Rework Validation including writing Protocols and Test Reports

Was part of CAPA team for Packaging and IFU for different countries and performed CAPA Effectiveness Check after implementation of new IFU after six months

Created ECO’s for new Products and Documents

Created, Updated and modified manufacturing process validation master plans & reports

Help in design transfer and manufacturing transfer of new products

Identify problems in existing/new processes and devise corrective strategies to optimize the process

Assisted in DFMEA and PFMEA analysis of different medical devices and updated after product recall

Perform investigation and analysis of validation outcome and implement effective solutions to solve issues, if any

Statistical Process Control (SPC), Gauge R&R, Design of Experiment (DOE) and Capability Studies.

Provide technical support/troubleshooting for process and equipment issues.

Smiths Medical India Pvt. Ltd. (Contract Rio Grande) Jul 2014-Jun 2015

Developed/revised Standard Operating Procedures (SOPs), Work Instructions (WIs) and Incoming Inspection plans for reference use in blueprints/drawings, inspections and specifications

Coordinated and supervised the quality incoming, in-process and final inspection activities

Identified and developed qualification/validation plans for manufacturing processes of different medical devices

Executed validation activities (IQ/OQ/PQ/TMV) and subsequently trained manufacturing operators for validation activities in accordance

Updated and modified manufacturing process validation master plans & reports. Help in design transfer and manufacturing transfer of new products. Identify problems in existing/new processes and devise corrective strategies to optimize the process

Provide technical support/troubleshooting for process and equipment issues.

Established and maintained procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability

Traxit Engineers India Pvt. Ltd. Jul 2012-Jun 2013

Visual Inspection of Sigma mixer, Planetary mixer etc. and carry several tests like Hydro test, pressure test, Radiography test and Ultrasonic test. Making Reports and certificates of the test.

Develop and maintain Standard Operating Procedures (SOP) for the manufacturing line process/Train all manufacturing technicians and operators on SOP.

Travel extensively to maintain close customer contact and develop rapport with the customer.

Collaborated with seniors to save 8% supply cost with closely working with suppliers to ensure that all components met department quality standards.

Carrying out Validations OQ & PQ for Sigma Mixers.

Suggested the technique to reduce amount of scrap product waste, saving 10,000 pounds of material per year, lowering shipping cost by $7,000 annually.



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