Headline

Process Engineer / Sr. Quality Engineer

About

▪ Quality/Process Engineer with experience in Lean Six Sigma, Quality Control, Continuous Improvement Techniques, Data Analysis and Logistics with nearly 6+ years of experience in Lean manufacturing, Data reporting, Quality assurance. ▪ Quality engineer experience in Process improvement, Lean manufacturing, Packaging, Test method validation and Equipment qualification in Medical device industry. ▪ Experience in CAPA, NCR, GAP Analysis, proficient in lean manufacturing concepts. ▪ Good experience in grading suppliers, developing supplier matrix and preparing Supplier Corrective Action Reports (SCAR) ▪ Organized continues improvement meetings and trained workers regarding 5S practices. ▪ Experience in using Six Sigma tools- FMEA, Root Cause Analysis, and Statistical Process Control (SPC). ▪ Highly experienced in Corrective Action and Preventive Action (CAPA) procedures and implementation of Change Management/Control. ▪ Experienced in evaluation of Manufacturing & Service work instructions and developing a test method to evaluate the risk and validate them. (Functional testing/Risk Assessment) ▪ Expertise in Remediation activities and experienced in validating work instructions for Production, FQA (Final Quality Assurance), IQA (Incoming Quality Assurance), Part Inspection Plans (PIPs) and Machine shop. ▪ Ability to apply Gage R&R and statistical tools towards validation and evaluation of measurement methods. Used Minitab software to analyze the data. ▪ Well-versed with Six Sigma concepts, Statistical Process Control, Design and Process Failure Mode and Effects Analysis (D/PFMEA). ▪ Responsible for reviewing design and process changes and assess impact to assure reliability requirements are met. ▪ Experienced in using various charting techniques like Pareto chart, pie chart, scatter plot, whisker plots to analyze the data. ▪ Authored operational, maintenance and calibration procedures for production equipment, test equipment and utilities. ▪ Have Knowledge in determining the requirements, Source determination, Selection of Vendor, processing and monitoring of Purchase order with Goods receipt and Invoice.

Location

Hyderabad

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claude

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Adobe Firefly

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Work experience

Process Engineer at DePuy Synthes, May 2021 - Present · 5 yrs 7 mos, Warsaw, Indiana, United States, • Work on projects that would improve the production process using lean principles and project management processes. • Provide Support to attain key business metrics through the provision of Engineering support for Value stream process. • Developing Stable and Capable manufacturing processes through a structured process development approach. • Manage the consumable budget for the assigned value stream identifying opportunities for cost reduction and managing the delivery of savings. • Actively work with the cross-functional team members, practicing good organizational structure requirements in support of day to day operating. • Work on implementation of all Engineering and plant strategic initiatives. • Elimination of safety and quality risks in the process through the delivery of robust engineering solutions. • Root Cause Analysis and implementation of robust solutions to supply and quality issues as they arise through tools such as A3 and Six Sigma. • Ensure timely closure of quality actions such as Audit Actions, NCR’s, CAPA’s.

Quality Sr Engineer I at Zimmer Biomet Dental, Sep 2020 - Jul 2021 · 11 mos, West Palm Beach, Florida, United States, • Worked on multiple MTP’s to provide data for monthly CAPA trigger meetings. • Conducted NC workshop to streamline the NC process, in order to improve the documentation quality, reduce the NC processing lead time, and eliminate redundancy • Worked on Profilometer Test Method Validation, this equipment is used to inspect the surface roughness of the blasted implants. • Worked on CAPA related to a Product issue where the operator was using unclean trays during the Final inspection and resulted in contaminated parts to the Customers in ETQ. • Worked on a project to minimize a feature inspection for TSV Parts and reduced the inspection time from 1 week to 3 days. • Worked on a project to minimize the redundant TSV EOL packaging inspection and implemented the QC audit process. • Worked on a project to minimize the redundant TSV Post blasting inspection and implemented the QC audit process. • Worked on TSV EOL Packaging Kaizen and improved the process cycle time from 55 secs/unit to 26 secs/unit with a 79% of improvement. • Trained multiple Engineers on production processes between multiple value streams. • Supported LISI screw transfer project by updating Quality Inspection Procedures, Inspection Sheets, Control Plans, and Visual Standards. The product was transferred from supplier to internal production. • Worked on QC sampling plan reduction project and reduced the inspection time from 2 days to 1 shift. • Worked on a project to eliminate the QAI1 inspection operation and implemented an audit process as part of the Quality at the sourcing initiative. • Worked on TSV abutment packaging harmonization project and reduced the cost from $4.54 to $0.50 • Worked on QCIF inspection reduction project to eliminate the redundant QC inspections performed in CORE products. • Conducted Several training sessions to operators to reduce the NC initiation and GDP errors.

Quality Engineer at Zimmer Biomet Dental, Apr 2018 - Sep 2020 · 2 yrs 6 mos, Palm Beach Gardens, Florida, United States, • Continuous Improvement: Conducted and executed a Kaizen event to restructure the LDA abutments Incoming to allow for operators to move the Jobs to Machining operation, which improved margins by 28%. • Worked on more than 350 NC’s within one year within PSP areas on several product issues and process issues. • Perform Calibration assessment for the newly implemented gages, inspection equipment’s. • Work on Corrective action and Preventive action activities to improve the production processes and work flows. • Worked on a project to reduce the GDP errors and reduce the documentation time, reduced 53 % of paperwork, 50% of reduction in entries, and 50% reduction in GDP errors was achieved. • Experienced in performing Benefit Estimation Calculation for the project that I worked on. • Support Lean Eco System project that resulted in machine layouts to improve the production time, product quality and reduces day to day machining issues. • Worked on Aged NC’s and closed about 45 NC’s in 3 weeks of time, thus improved the Aging NC trending from 54 % to 82% (Goal > 80%). • Worked on Illegible Label CAPA and implemented a fixture for the label printers to improve the printing process as part of the corrective action.

Quality Engineer at Noramtec Consultants Inc., Apr 2017 - Apr 2018 · 1 yr 1 mo, Palm Beach Gardens, Florida, United States, • Experience in creating monthly and quarterly trending of NC’s occurred in the PSP area. • Implemented IQ for Starrett Comparator used for in-process inspection in PSP machining area. • Implemented DCR to improve the Inspection criteria for TSV abutments by increasing the fixed pin diameter which covers more surface area when part placed on the pin and hold the part firmly during the inspection. • Performed Test method validation for Sterility Barrier of Vials and Caps transfer parts • Developed Inspection sheets for the parts as part of Transfer Project from Carlsbad. • Wrote test methods for some existing work instructions. Performed GAP Analysis and prepared Remediation Plans to fix the identified gaps. • Experienced with protocol deviation/root cause analysis planning, execution and documentation. • Experienced in statistical data analysis using Minitab (Gage R&R, Anova studies) and Distribution Analyze. • Working on 2 CAPA related to PSP area for Missing Design files and Mixed parts due to serial number mismatch. • Responsible for providing engineering support in manufacturing processes as well as perform root cause analysis of existing products. • Responsible for maintaining Quality System Regulations including Document Control and Record Control.

Industrial Engineer at Nirmal Industrial Controls Pvt. Lmt, Mar 2014 - Aug 2014 · 6 mos, India, • Planned the scheduling for production on daily basis and manage the man power to achieve the daily production targets. • Responsible for analyzing the material, equipment and tools requirements according to production plan. • Designed manufacturing layout to customize product flow thus reducing cycle time by 6%. • Preparation of various types of Reports (Job Card, FPI, DPR, Scrap, WIP Stock, Daily Preventive Maintenance, Breakdown Logbook) for the production review. • Ensuring the quality control and production analysis. • Making use of engineering knowledge to solve technical and management problems. • Developed knowledge of various quality analysis and process mapping techniques. • Used various charting techniques like Pareto chart, pie chart, scatter plot, whisker plots to analyze the data. • Improved manufacturing efficiency by analyzing and planning work flow and equipment layout. • Prepare and review drawings detailing the design, drawing modification, making CAD and updating drawing and their BOM in ERP.

Education

Master's degree, Engineering/Industrial Management, Texas A&M University-Kingsville

Bachelor's degree, Mechanical Engineering, Jawaharlal Nehru Technological University