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SUMMARY
•ASQ Certified Quality Engineer (CQE).
•Certified Six Sigma Black Belt (SSBB) and Six Sigma Green Belt (SSGB).
•Extensive experience in Process Validation, Manufacturing Process Control, Risk Management, Process Improvement and Quality Control for Medical Device Manufacturing.
•Initiated and investigated Corrective and Preventive Actions (CAPA) taken for nonconformance.
•Extensive experience on Test Method Validation (TMV) for analytical attribute and variable dimensional measurements.
•Worked with cross functional teams on Risk Assessments (FMEA and FMECA) and Design Control.
•Subject Matter Expert (SME) for Cleaning and Packaging Processes.
•Strong working knowledge of DMAIC/DFSS and Lean techniques.
•Experienced in application of statistical Design of Experiments (DOE) and process optimization.
•Extensive experience with material testing and metrology instruments.
•Accomplished at writing Standard Operating Procedures (SOP), Work Instructions, Technical Protocols, Technical Reports, Equipment Specifications, Calibration Limits, and procedures for medical device process.
•Expertise in Gage Reproducibility and Repeatability (Gage R & R) studies.
• Strong Understanding of MSA, SPC, Process Monitoring using Control Charts, Attribute and Variable Sampling Plans.
•Proficient at preparing, executing and reviewing IQ, OQ, PQ protocols and summary reports.
•Solid management skills, demonstrated proficiency in leading & mentoring individuals to maximize level of productivity, while forming cohesive team environment.
•Highly motivated team player with vision to succeed.
•Analytical personality with excellent investigative skills.
•Ability to adapt to the changing need of the organization.
•Ability to work in and with diverse groups.
•Expert on Microsoft office tools (Word, Excel, PowerPoint, Gantt chart, Outlook etc).
•Operating knowledge of CNC Milling machines, CMM dimension measurement machines, Mass Finishing machines, Polishing and Cleaning Machines.
WORK EXPERIENCE
Manufacturing Engineer FEB, 2012-Present
Zimmer Inc., Warsaw IN
Responsibilities:
•Responsible for providing engineering support in hip manufacturing processes as well as perform root cause analysis of existing products.
•Provide input into Material Review Board (MRB) for Disposition of Non-Conforming materials.
•Writing and Executing and reviewing Installation, Operational and Performance Qualification Protocols to comply with USA FDA 21 CFR 820 and ISO 13485.
•Preparing Zimmer Work Instructions, Standard Operationg Procedure, Measurement Inspection Sheet and Zimmer Engineering Specifications.
•Served as a Validation Core Team Member (VCT) to providing Validation documentation and execution expertise, support and guidance to manufacturing departments.
•Worked on Process Validation Remediation (gap analysis, risk assessments, re-validation).
•Assuring compliance with FDA: Global Harmonization Task Force, cGMP and QSR.
•Retrofitted final cleaning equipment for continuous control of process parameters.
•Developing optimized models by investigating and conducting DOE on new or current processes.
•Implementing Lean and Six Sigma concept on manufacturing process to reduce manufacturing cost.
•Initiated Corrective and Preventative action (CAPA) plans with root cause analysis.
•Applied Statistical process control (SPC) method for analyzing data to evaluate the current process and process changes.
•Conducted Reproducibility and Repeatability studies using Minitab.
•Devised sampling procedure and design and develops forms and instructions for recording, evaluating and reporting quality and reliability data.
Researcher AUG 2008- AUG 2011
University of Central Oklahoma (UCO), Oklahoma
Responsibilities:
•Conducted Breast cancer treatment experiment on animals with combination of laser energy and drugs (glycated chitosan) that enhance the immune system.
•Understood the Laser thermal effect on tumor cells Vs surrounding tissues using Nuclear Magnetic ...
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