Deepika Negi - ASQ CQE

Address: ** **** *** *****, ************, NJ 07840 Phone: 682-***-**** Email: adcgvo@r.postjobfree.com PROFESSIONAL SUMMARY

Certified Quality Engineer with experience in quality engineering, lean manufacturing product/process design and NPD. Deliver quality controls and enhancements to proactively address problems and improve product quality, manufacturing flow, customer satisfaction and bottom-line results.

TECHNICAL EXPERTISE

Working Knowledge of Quality Tools (FMEA, Pareto Charts, A3, Fishbone Diagrams, Six Sigma, 5S, 5Why, 8D Methodology), Kaizen, PDCA (Plan Do Check Act), GD&T (Geometric dimensioning and tolerancing)

Experience with Plastic Injection and Compression molding.

Software – AutoCAD, Solid works, Minitab, Microsoft Excel, SAP.

Knowledge of PPAP, APQP, QMS (Quality Management System).

Excellent in written and communication skills, team player with great leadership capability, analytical and problem-solving skills.

PROFESSIONAL EXPERIENCE

Quality Engineer Albea America USA August 2018 - Present

Investigating, implementing Corrective and Preventive actions (CAPA) and responding to customer related issues using a formal 8D & 5 Why within a timely manner.

Reduced Key Customer Complaints by 50%.

Monitor / analyze production performance trends for Key Quality Metrics and establish appropriate control measures.

Performed Gage R&R to ensure repeatability and reproducibility of measurement tools.

Reduced process variation by performing capability studies and implementing SPC.

Creating and updating Work Instructions, Standard Operating Procedures (SOPs), Visual Quality Standards as per ISO 9001:2015 standards.

Involved in development and execute Validation Protocols (IQ, OQ, and PQ) and reports.

Managed the installation of Zero-Defect Systems on lines, which decreased production spoilage.

Issuing and reporting Nonconforming Material Reports (NCR) found during the production process and involved in making Material Review Board (MRB) decisions.

Led Internal audits and assisted Quality Manager in Customer Audits, Hygiene Audit & ISO 9001 Recertification Audits.

Managed Supplier Corrective Action Request (SCAR) system.

Participated in development of FMEA, Control plans and Design of Experiment (DOE).

Contribute to the launch and transfer of new products to production through the NPI process.

Manufacturing Quality Engineer TekWissen (Zimmer Biomet) USA June 2018 – August 2018

Investigating, implementing corrective/preventive actions using a formal 5 Why approach.

Prepared Quality Trends monthly to review the performance of production line in the plant.

Preparation of quality inspection plans, procedures and practices as per ISO 13485 and ISO 9001.

Conduct monthly 5S Audits, Food Safety Audits, & EHS audits of the company.

Using a DMAIC along with Lean Engineering principles to approach problem solving and continuous improvement.

Participated in Continuous Improvement activities. EDUCATION

Master of Science (MS) Mechanical Engineering-University of Texas At Arlington, USA Bachelor of Technology (BS) Mechanical Engineering-University of Mumbai, India CERTIFICATION

ASQ-Certified Quality Engineer CATIA V5

KEY SKILLS

Lean Manufacturing Operations

Six Sigma

Process Development & Improvement

Poka-Yoke, PFMEA, MSA

Quality Assurance

Problem Solving

Quality Auditing

ISO 9001 & ISO 14001

GMP, GDP

Statistical Process Control (Cp &Cpk)

Root Cause Analysis

Scrap Reduction & Output Increase.

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