Professional Documents
Culture Documents
Professional Summary:
Enthusiastic Quality Engineer eager to contribute to team success through hard work, attention to
detail and excellent organizational skills. 3+ years of professional experience along with expertise
in Root Cause Analysis, Process validation, Continuous quality improvement, strong understanding
of Computer Aided Design, Engineering, Analysis and Manufacturing. Passionate about problem-
solving, highly energetic, and always aimed to delivering highly profitable manufacturing
processes.
Education:
Bradley University, Peoria, IL
December 2019
Master of Science, Mechanical Engineering
Dr. BAMU University, Aurangabad, India July
2017
Bachelor of Engineering Mechanical Engineering
Professional Experience:
Philips Health Care IGTD April 2021 -
Present
Quality Engineer
Responsible for Product evaluation, Complaint Handling with risk management and Non-
Conformance
Reviewed Engineering Change Order (ECO), and Manufacturing Change Order (MCO)
Wrote, reviewed, and approved change orders to improve manufacturing processes and quality
procedures
Involved in project management and product life cycle management of the design process
Participated in developing EU MDR Documentation for Notified Bodies
Conducted remediation for medical equipment in an US FDA ISO 13485,14971 and current Good
Manufacturing Practice (cGMP) regulated environment
Involved in Process Validation and Test Method Validation (TMV)
Reviewed and authored test protocols and reports for Installation Qualification (IQ), Operational
Qualification (OQ), and Process and Performance Qualification (PQ/PPQ), Test Method Validation
(TMV) and Gage R&R,
Master Validation Report (MVR), Statistical justification of test sample and lot sizes, and Quality
Monitoring Assessment Plan
Reviewed Risk Assessment Documentation, reviewed Corrective and Preventive Action (CAPA)
and drafting Remediation Plans for the project management approval after the GAP Analysis
Involved in ensuring development activities were properly documented through design control such
as Risk Analyses (pFMEA), Protocols, ensure compliance with internal quality system in
accordance with Quality System Regulations (QSR) and ISO standards
Applied quality engineering practices and guidance to support project teams and manufacturing
operations using SPC tools, FMEA, cause &: effect Matrix and control plans
Co-Authored and executed IQ, OQ, PQ for new equipment and when changing existing
manufacturing equipment
Honda of America Manufacturing, Inc, East Liberty Auto Plant 2020 -
April 2021
Manufacturing Process Associate
Gained experience with topcoat, sealer, e-coat, paint off, final repair and Vehicle quality
department for paint work such as inspection, quality checks at quality gate for all the models such
as HONDA CRV, ACURA RDX and ACURA MDX.
Managed GALC Tracking System for defects and solved problems related to paint issues
Performed troubleshooting for processing issues and assessing process orders for the defects and
assisting in improving the production quality for mass production of New Model
Team Leader of Fast & Furious Honda NHC team at Honda of America East Liberty working on
development of tracking system for paint repair parts for delivery and inventory management
Utilized SPC tools (Cause and effect diagram, Pareto analysis Ishikawa/fishbone diagram) to
identify and reduce the process variation related to paint repair parts for delivery and inventory
management