Engineer Quality

SUMMARY

Quality Engineer at Zimmer Biomet(Adecco).

Industrial engineer with extensive knowledge of Reliability, Statistical Process Control (SPC), Preventive Maintenance, Corrective Maintenance, quality management, Inventory management

Six Sigma Green Belt Certified Engineer, IISE, #2536-18026

Experienced as Quality Assurance Engineer at R.S. Foils Pvt Ltd. An Aluminium foil industry which caters need of food and drug companies and as Maintenance Engineer performing regular maintenance and Plant Shutdown Maintenance.

I am Adept to ISO 13485:2003, 21 CFR 820, ISO 14791 and ISO 9001-2005.

Extensive Experience in Problem Solving, DMAIC, Root Cause Analysis, FMEA, SPC, Corrective and Preventive Actions, Reliability, Human Ergonomics, and Simulation.

Extensive knowledge of Minitab, AutoCAD, Arena Simulation, Mathematic, Microsoft Office, C++, MS Word, Excel, PowerPoint, Working knowledge of ERP and SAP.

EDUCATION

Lamar University, Beaumont, TX May 2017

Master of Engineering in Industrial Engineering.

Developed leadership, facilitation, communication, and public relation skills by assisting new and transfer Students at Lamar University

Gujarat Technological University, Gujarat, India May 2013

Bachelor of Engineering in Industrial Engineering.

WORK EXPERIENCE

QUALITY ENGINEER AT ZIMMER BIOMET, WARSAW, INDIANA JAN 2018 – PRESENT

•Working with cross-functional teams to develop Validation and Verification Protocols, Implementing the Validation and Verification activities, developing and approving reports ensuring compliance to 21 CFR 820, ISO 13485, ISO 14791 and Other Regulations.

•Ensuring timely disposition of Non-Confirming Material.

•Reviewing and approving Engineering Change Notifications

•Developing testing methods, writing quality testing procedures, and checking quality to ensure compliance.

•Lead CAPAs and ensure implementation of the Corrective Actions with proven effectiveness.

•Performing root causes analysis of failures medical parts.

•Identifying shortcomings of Standard Operating Procedures and Work Instructions and update them to show compliance to 21 CFR 820, ISO 13485, ISO 14791, and other Regulations.

QUALITY ENGINEER AT R.S. FOILS PVT.LTD, GUJ, INDIA MAY 2013- JUNE 2015

•Revised SOPs (Standard operating procedures) for all manufacturing processes to ensure that the product met the requirements.

•Consulted clients to solve their quality related problems.

•Reviewed, approved, and generated Engineering Change Notifications (ECNs) to update or generate: verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s).

• Reviewed non-conformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.

•Ensured containment (identification, segregation, and reconciliation) of nonconforming product has been performed, to prevent unintended use.

•Coordinated with cross functional team including Purchasing Representative and the suppliers to conduct raw material specification review, create RIPs (Receiving Inspection Plans), determining Sampling Plans etc. for new as well as current components.

•Coordinated with customer to review the Product Design and establish the requirements.

•Conducted training for operators to ensure that they adhered to the Standard Operating Procedures and work criteria to maintain product quality.

Maintenance Intern, At Transpeck Sil+ox Industries Ltd., Vadodara, India. December 2012- May 2013

•Analysed Daily maintenance problems and documented the report with findings.

•Coordinated with cross functional team to successfully complete all preventive maintenance activity.

•Assisted Mechanical Maintenance Engineer in Plant Shutdown Maintenance.

•Created Reports on Time based Maintenance and Corrective Maintenance with data of spares, working hours and detailed description of problem.

•Reported all training sessions given by maintenance manager and Safety department to maintenance fitter and helpers.

ACADEMIC PROJECTS

Simulation and Optimization of Small Manufacturing Line by Using Rockwell Arena: Created a model in Rockwell Arena based on time study and time data and compared different scenarios with Input Analyzer, Process Analyzer and OPT Quest

Risk management in global supply chain: Evaluated different risk associated in global supply chain and utilized different tools and techniques of risk management such as Preliminary Hazard, HAZOP, FTA, FMEA, ALARP, Fault & Event Tree analysis

Processing Transactions through the Logistic and Support Processes of SAP: Performed transactions and business processes in SAP, worked on Production Logistics (PP), Sales & distribution and FI/CO modules and prepared sales orders and posted good issued using the Sales and Distribution (SD) module

Evaluating user discomfort on distinctive style and size of heels: Selected by the 8th International Conference on Applied Human Factors and Ergonomics (AHFE 2017). Performed Experiment and surveys to understand the effect of high heels on human body and evaluated user discomfort on different style and height of heel.

Evaluation of squatting stool: Based on result, we suggested a backrest or handrail is needed for common sitting toilet. The squatting stool should be design as adjustable in order to release the stress on leg.

Design of clamp on robot to weld flaps: Redesigned the clamps on robot to minimize timing in loading and unloading of flap. We reduced time by 8 mins per flap.

PROFESSIONAL ORGANIZATIONS AND LEADERSHIP

Member, American Society for Quality (ASQ) August 2016 - Present

Member, Institute of Industrial and Systems Engineers (IISE) August 2016 - Present

Orientation Leader, Office of International Student Services August and December 2016

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