Experienced Quality Engineer with hands on knowledge of Root Cause Analysis, Continuous Improvement and First Article layouts.
Experience with Corrective Actions (CA), Quality Approval for non-conforming parts, performing Gage R&R, inspect and test products and components with different types of gages.
Experience in writing protocols for Corrective Actions, analyse and summarize Gage Rejection Notice (GRN) and investigating non-conforming reports (NCR).
Master of Science in Industrial and Systems Engineering
University of Texas at Arlington, TX, USA Aug 2014 – May 2016
Bachelor of Engineering in Mechanical Engineering
University of Pune, India June 2010 – May 2013
Health Hazard Evaluation Decision (HHED)
Non-conformance Report (NCR)
First Article Layout (FAL)
Standard Work Procedures (SOP’s)
Root Cause Analysis
Time and Motion Studies
Gage Rejection Notification (GRN)
Corrective Action (CA)
Quality Engineer, Zimmer Biomet, Warsaw, IN, USA Sept 2017 - Present
Perform Inspection Criteria Change requests and approvals through Change Management System (CMS) as part of continuous improvement.
Lead cross functional teams through the 8D process to identify the root cause of failures.
Work with Quality and Development Engineers to build an effective manufacturing process for non-conformance of product.
Analyse, execute and summarize Corrective Actions (CA) in support of Gage Rejection (GRN’s) and non-conformance of product.
Knowledge on Blueprint readings, Geometric Dimensioning and Tolerancing.
Investigate the non-conformance reports (NCR) of the inspection failure components and perform required inspection with multiple measurement tools.
Apply Good Documentation Practices (GDP) to ensure inspection results following QP (Quality Process).
Perform Root Cause Analysis into NCR Investigation for Knees implants.
Working knowledge on Health Hazard Evaluation Decision (HHED), Product Hold and Quality Hold.
Quality Engineer, Zimmer Biomet, Warsaw, IN, USA April 2017 – Sept 2017
(Metrology and Calibration)
Working with CAPA team to monitor all CAPA related activities within the company including retrospective remediation, analysis and addressed gaps of CAPA records.
Create timelines, closure documents and write protocols for the CAPA’s.
Involved in Continuous Improvement on pin gages project to remediate them and replace the ones’ which are ineffective to company by ordering new.
Eliminate the use of non-calibrated gages for product inspections.
Working knowledge on First Article Layout (on test products) and Gage R&R.
Process Improvement Intern, UT Southwestern Medical Center, Dallas, USA June 2016 – Aug 2016
Performed Time and motion study to reduce the patient wait times at Imaging Center.
Prepared control charts and process maps to improve the process performance and process capability.
Created and analyzed the value stream maps to remove/minimize non value added activities.
Junior Engineer, ACE Metal Treaters Pvt. Ltd, Pune, India Aug 2013 – June 2014
Implemented continuous improvement to reduce waste, inventory and non-value adding activities to improve productivity of the firm.
Analysed the reasons for rework, scrap, etc. and worked on to provide better quality as appropriate.
Implemented FMEA to the analysed data to find out the reason for failure of service.
Took initiative, implemented and trained employees about Kaizen techniques.
Standardized and streamlined the work flow based on 5S techniques.
Worked on ISO 9001 documentation and prepared Standard Operating Procedures.
Microsoft Office Tools: MS Excel, MS Visio, MS Word, MS PowerPoint.
CAD Software’s: Auto-Cad 2010, Catia V5 R19, Solid Works, Unigraphics NX 6.
SAP Software’s: ETQ, AS400, Infor ERP XA.
Lean Six Sigma Green Belt Certification.
ISO 9001 QMS Auditor Certification.
Diploma in Tool Engineering.
Quality Improvement and Patient Safety (UT Southwestern Medical Centre).
PLC, SCADA, HMI, Auto-Cad (2010).
SAP Certification Award.