Quality Engineer

SANKET KOSHIYA Raleigh NC, ***** aczbci@r.postjobfree.com (323) - 847 - 8271

SUMMARY:

Hold a Master’s Degree in Mechanical Engineering from California State University, Los Angeles with three years experience in various type of medical devices, development, manufacturing, new product introduction, process validation and Quality Control and R&D (CAD) in both Automotive and Medical Device.

Extensive knowledge of Lean Manufacturing, Six Sigma, IQ, OQ, PQ, Corrective and Preventive Action (CAPA), Validation & Verifications (V &V), FDA Medical standard, ISO9001, DMAIC, FEA, FMEA, DOE, SPC, GD&T, 5S, 5WHY, RCA, 8D, APQP, PPAP, Gage R&R, Fishbone diagram,, and TS 16949 specifications.

Experience in implementation and maintain ISO 9000, 14001, TS 16949 and GMPs for Manufacturing process.

Reliability and maintainability using predictive and preventive maintenance tools and evaluation of performance measures like productivity, process capability, Cp, Cpk, Cpm.

Well versed with FDA’s CFR Title 21 Part 820 Quality Systems Regulations (QSR).

Certified in SolidWorks (Dassault), Six Sigma Master Black Belt and Lean Six Sigma Green Belt.

Proficient in creating detailed mechanical 2D and 3D drawing in SolidWorks, Inventor and AutoCAD.

Ongoing towards Engineering in Training Certification (E.I.T). Willing to relocate.

Flexible and reliable with superior work ethics and high professionalism.

Motivated, results oriented ability to grasp concepts and seek new solutions. EDUCATION:

California State University - Los Angeles, CA Sep. 2015 - Dec 2016 Master of Science, Mechanical Engineering, GPA: 3.65/4.0 Coursework: Manufacturing, Production planning and Development, Automation and CAM, Machine Design, Industrial Engineering, Vibration Engineering, & Thermal Radiation. TECHNICAL PROFICIENCY:

Analysis Software Computer Skills Manufacturing

Finite Element Analysis Simulation(FEA) SolidWorks Six Sigma Manufacturing Scanning Electrode Method(SEM) Inventor Lean Manufacturing Measurement System Analysis (MSA) AutoCad 5S, GD&T, 8D Gage R&R Studies Minitab 17 Product Part Approval Process(PPAP) Coordinate Measuring Machine(CMM) MS Office Statistical process control (SPC) Root Cause Analysis (RCA) MathCAD Advanced Product Quality Planning(APQP) CERTIFICATIONS/ COURSES:

Six Sigma Master Black Belt, License 784***********, International Six Sigma Institute, August2016 Certified SolidWorks Associate, C-8J7T59E92D, Dassault System, May 2016 Lean Six Sigma Green Belt Certification, License 5MQxHslqBH, Prosource Professional Certification, Jun 2016 Validation / Quality Management

PROFESSIONAL EXPERIENCE:

GKN Driveline Newton, North Carolina, USA March 2017- Present Quality Engineer

Resolve problems, make process improvements and respond to internal and external customer inquiries regarding quality issues.

Perform compliance and system effectiveness audits to insure adherence to company policies, procedures and customer requirements.

Lead the Advanced Product Quality Planning (APQP) Process for new products and processes

Use inspection gages and tools to collect process data.

Participate in design reviews and development of process FMEA and take appropriate actions.

Lead teams in structured problem solving efforts to improve both product and processes.

Communicate directly with internal and external customers to resolve disputes involving product quality, concerning product, service and deliveries and in technical discussions as needed.

Perform internal supply evaluations and track corrective actions driven through seven step process. SANKET KOSHIYA Raleigh NC, 27519 aczbci@r.postjobfree.com (323) - 847 - 8271

Coordinate Production Part Approval Process (PPAP) to Ford, GM, FCA, Maserati and Cadillac.

Perform all other task as assigned by Internal Quality Manager. Honor Plastics & Molding Inc. - Ontario, CA, USA March 2016- December 2016 Quality Engineer Mechanical Design Engineer

Researched and analyzed customer design proposals, specifications and requirements.

Designed plastic parts such as Medical device products, boxes, plastic bottles, elbows, glass cups, toy parts, and automotive parts using SolidWorks. Created 2D, 3D, and sheet metal drawings using SolidWorks.

Reviewed blueprints to understand Geometric Dimension and Tolerancing (GD&T).

Completed First Article Inspections (FAI) by using a Coordinate Measuring Machine (CMM).

Implemented Advanced Product Quality Planning (APQP), created Product Part Approval Process (PPAP).

Performed Statistical Process Control (SPC), Measurement System Analysis (MSA or Gage R&R), Design of Experiments (DOE), Control Charts by using Minitab Statistical Software.

Performed continuous process inspection and visual inspection on finished products, and maintained the tolerances within desired limits using calibration tools such as micrometers, calipers, gauges, and performed hardness.

Performed Failure Mode Effect Analysis (FMEA), Non-conformance report (NCR) and Corrective- Action/Preventive-Action (CAPA). Prepared Bill of Materials (BOM) and inventory sheets.

Prepared and executed Installation Verification and Operational Testing protocols.

Prepared and executed Installation Qualification (IQ) protocols for equipment.

Prepared Validation Plan and Risk Assessment protocols for E&AS. Raytech Medical Manufacturing Inc. May 2013 – May 2015 Quality Engineering / Validation Engineer

Implemented and maintain FDA Standard, ISO 9000, 14001, and GMPs for Manufacturing process.

Implemented Advanced Product Quality Planning (APQP) and Product Part Approval Process (PPAP-AIAG).

Improved quality by using Measurement System Analysis (MSA) and Statistical Process Control (SPC).

Prepared Failure Mode Effect Analysis (FMEA), Control Plan, and tested Scanning Electrode Method (SEM).

Successfully applied Corrective-Action/Prevention Actions (CAPA) and performed online inspection.

Reliability and maintainability using predictive and preventive maintenance tools and evaluation of performance measures like productivity, process capability, Cp, Cpk.

Established Preventive Maintenance Plan working in a 5S work culture and prepared daily production reports.

Reviewed Design History File (DHF), Design History Report (DHR) and process specifications.

Successfully completed root cause findings using 5 WHY’s and Participated CAPA committee meetings during approval of different phases of CAPAs.

Analyzed the inspection report including the CMM report, Statistical Process Control (SPC), manual Gage measurements and so on.

Working knowledge of production floor on various phases of production through finishing while also having the knowledge of Non-Conformance Report (NCR).

Contact this candidate