Anisha D. Kaul
Canal Fulton,USA
Summary
Over 16 years’ experience of quality engineering, statistical analysis, quality improvements and quality project management. Over 12 years of working experience in manufacturing and quality assurance in an FDA regulated medical device industry incompliance with ISO13485. Master of Science in Bioengineering, University of Texas- Arlington Bachelor of Science in Electrical Engineering, India. ISO 13485:2003 Lead Auditor Training, AAMI Quality Systems Requirement and Industry Practices and ISO 9001 Internal Auditor training program. Certified Lean Six Sigma Black Belt, Statistical Process Control (SPC), Minitab, Quality Trainer, SAP-ERP and EtQ Excellent communication, team building and interpersonal skills.
Overview
20
20
years of professional experience
Work History
Sr. Quality Engineer I - Validations
ZIMMER SURGICAL INC.
01.2016 - Current
- Providing validation support by performing testing, establishing validation standards, developing testing protocols, preparing equipment, document test results and maintain records for later analysis
- Manage all equipment qualification, cleaning and process validation activities and projects
- Initiate and execute protocols for manufacturing, utilities and lab equipment processes
- Design of Experiments, Measurement Systems Analysis, Process Capability and Statistical Process Control
- Plan, coordinate and track the progress of validation projects
- Compile validation packages and assure all required documentation is accurate and complete
- Lead investigations related to validation deviations and assure thoroughness of investigation, documentation and closure
Quality Assurance- Manufacturing and Design Transfers
ZIMMER SURGICAL INC.
01.2014 - 01.2016
- Coached and mentored Quality Technicians for their daily functions within the manufacturing areas
- Provided quality assurance and quality engineering support to existing Manufacturing Operations
- Formulated recommendations for product disposition or other actions related to product nonconformance and field performance issues
- Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures
- Responsible to review and approve quality investigations to ensure complete documentation
- Provided risk assessment HHE’s (Health Hazard Evaluations) on product nonconformance and field performance issues
- Supported Corrective Action Preventive Action (CAPA) projects and investigation of root cause for Product Investigation Report (PIR)
- Reviewed Internal Audit (IA), Deviation, Out of Specification (OOS), and Supplier Corrective Action Notification (SCAN) responding reports
Supplier Quality Engineering
ZIMMER SURGICAL INC.
01.2012 - 01.2014
- Evaluated and dispositioned supplier caused non-conformances and drive risk based corrective action to prevent recurrence
- Lead and collaborated with cross-functional teams to manage supplier change notifications through risk-based evaluation
- Provided input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
- Assisted with the analysis and resolution of sourced material issues as these arise
Quality Assurance
Welspun Pipes Inc.
Little Rock, AR
01.2008 - 01.2012
- Statistical Process Control
- Process Capability Study: Analysis of the process capability of the manufacturing shop using statistical tools and monitoring compliance to corrective actions
- Process Improvement: Identifying process variances originating in machines and product flow and directing efforts towards process improvement
- Prepare technical documentation such as technical reports, engineering studies and other documentation as required
- Ensure effective closure on Quality System documents (Audit Actions, ER's, CAPA's, etc)
- Monitor and report out on Quality Corrective Action; Maintain gage calibration system
- Review existing processes to identify and implement cost savings, and improvement in quality and productivity
- Provide a strong analytical approach to problem solving and bring innovative solutions to equipment issues
Graduate Research Assistant
University of Texas- Arlington
Arlington, TX
01.2007 - 01.2008
- Commissioning and troubleshooting the state-of-the art analyzers for lab research
- Performing probe design for the analyzers according to the needs of the experiments
- Responsible for creating the proof of content, Design of Experiment (DOE), data acquisition, data analysis, drawing conclusions and carrying out iterative studies
- Design of the experiment and detailed product analysis, collection of subjects and data acquisition, optical data analysis, observing result oriented analysis
- Coordinating with other research labs to discuss results of research
- Calibration and Testing of machines used for production
- Studying the results of tests to validate research approach and methods
Intern
Induction India Pvt
, India
01.2005 - 12.2005
- Engineering Design of the PLC system for automated material handling in the induction heating shop, its integration with the existing layout, testing of the instrumentation, calibration and successful commissioning
- Developed product from concept to rapid prototyping of the system and forming of the control panel and wiring circuitry for the entire Autoloader system
Education
Master of Science - Bioengineering
University of Texas- Arlington
ArlingtonBachelor of Science - Electrical Engineering
IndiaSkills
- Lean manufacturing principles
- Regulatory compliance understanding
- Statistical process control
- Six Sigma Methodologies
- Cross-Functional Teamwork
- Quality System Processes
Summerinternship
Induction India Pvt, India, 01/01/05, 12/31/05, Engineering Design of the PLC system for automated material handling in the induction heating shop, its integration with the existing layout, testing of the instrumentation, calibration and successful commissioning., Developed product from concept to rapid prototyping of the system and forming of the control panel and wiring circuitry for the entire Autoloader system.
Professionalacademicstrengths
16, 12, Master of Science, Bioengineering, University of Texas- Arlington, Bachelor of Science, Electrical Engineering, India, ISO 13485:2003 Lead Auditor Training, AAMI Quality Systems Requirement and Industry Practices, ISO 9001 Internal Auditor training program, Certified Lean Six Sigma Black Belt, Statistical Process Control (SPC), Minitab, Quality Trainer, SAP-ERP, EtQ, Excellent communication, Team building, Interpersonal skills
Timeline
Sr. Quality Engineer I - Validations
ZIMMER SURGICAL INC.
01.2016 - Current
Quality Assurance- Manufacturing and Design Transfers
ZIMMER SURGICAL INC.
01.2014 - 01.2016
Supplier Quality Engineering
ZIMMER SURGICAL INC.
01.2012 - 01.2014
Quality Assurance
Welspun Pipes Inc.
01.2008 - 01.2012
Graduate Research Assistant
University of Texas- Arlington
01.2007 - 01.2008
Intern
Induction India Pvt
01.2005 - 12.2005
Master of Science - Bioengineering
University of Texas- Arlington
Bachelor of Science - Electrical Engineering
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