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Qms Document Control Specialist Resume

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Warsaw, IndianA

SUMMARY:

Highly - Motivated Materials and Quality Engineer With Extensive Experience on Manufacturing Processes (especially Additive Manufacturing or 3D Printing), Materials and Alloys Characterization, Piping, Welding (SMAW, GTAW, MIG, MAG), Heat Treatment, Sampling and Inspection, Testing (Destructive & Nondestructive), Quality (Planning, Assurance, Control, Improvement), Audit (Process, Product, and systems), Safety and Risk Assessment, Lean Manufacturing, National and International Standards, Codes, and Regulations (e.g. ISO, FDA codes, ASTM, ASME Codes, AWS,API, DS-1, etc.) ASQ CQE, Lean Six Sigma Black Belt, DS-1 Inspection, NDT, Safety, Audit, Risk Analysis

TECHNICAL SKILLS:

Software skills: MINITAB (for Statistical Analysis), ARENA (for Manufacturing Process Simulation), AUTOFAB and MAGICS (for Additive manufacturing), AutoCAD, PTC CREO and Solidworks (for Computer Aided Design), Microsoft Office, etc.

PROFESSIONAL EXPERIENCE:

QMS Document Control Specialist

Confidential, Warsaw, Indiana

Responsibilities:

  • Review and ensure that process validation documentations (i.e. IQ, EQ, MVP, VTM, DOE, OQ, PQ,) comply with company quality management system, medical devices industry standards (ISO 13485 & ISO 14971) and regulatory requirements (21 CFR 820)
  • Monitor maintenance status of equipment and calibration status of measurement instruments
  • Prepare and/or update Standard Operating Procedures (SOPs) and Work instructions
  • Working with different modules of EtQ (Compliance & Quality Management System software) and InfoPV (Process Validation and Test Method Validation Software)

Research & Teaching Assistant

Confidential, Texas

Responsibilities:

  • Study of selective laser remelting of 316L S.S. to reduce roughness on inclined surface (process & product improvement via design of experiment
  • Operated 3D printing (additive manufacturing) machine for manufacturing of metallic parts
  • Optimized process parameters for additive manufacturing of metallic alloys
  • Safely operated manufacturing processes shop machines and equipment (additive manufacturing, powder metallurgy, metal cutting, sheet metal forming, forging, injection molding, machining, heat treatment, welding, and cold rolling, etc.)

Quality Lead

Confidential

Responsibilities:

  • Assisted QHSE (Quality, Health, Safety, Environment) manager in implementation and maintain of company’s quality management system (QMS) manuals, procedures, and forms
  • Served as the company’s focal point for quality& materials & manufacturing & inspections with clients, service companies, third parties ( e.g. SGS, Bureau Veritas, DNV GL), and suppliers (manufacturers)
  • Prepared, reviewed, approved technical documentation including inspection and test plans (ITP's), manufacturing procedure specifications (MPS's), WPS & PQR, nonconformity reports (NCR),SCAR, failure analysis, scope of inspection,
  • Monitored all tools and equipment regular inspection and maintenance program to improve operation efficiency
  • Improved incoming products and services quality through evaluation, monitoring, and supporting suppliers’ quality policies, procedures, tools, and processes
  • Applied statistical and/or Quality tools (flow chart, cause & effect diagram, process behavior (control) chart, check list, histogram, Pareto chart, scatter plot, regression analysis, ANOVA, measurement system analysis (MSA), hypothesis, DMAIC, DOE, SPS,FMEA, 5 Whys, PDCA, 8D and so on) for processes, products, and services quality improvement
  • Supervised quality activities of Kish Well Completion Equipment factory (a subsidiary of company)
  • Conducted regular audits on vendors & suppliers to ensure supplier quality meets company and clients requirements

Materials Engineer

Confidential

Responsibilities:

  • Supervised quality, welding, painting, inspection, materials, documentation, HSE and mechanical aspects for the 12 units of combined cycle power plant (Engineering, Procurement, Construction) projects
  • Acted as direct Quality/Materials liaison with installation, Commissioning, Procurement, Contract, Planning Departments, Suppliers (Vendors), Contractors, Subcontractors, and Clients
  • Ensured that products and services comply with both client requirement and applicable international standards, codes, and regulations including ASME, ISO, API, ASTM, AWS, BS, DIN
  • Implementation and maintaining of quality management system ( ISO 9001, ISO 14001, OHSAS 18001)
  • Coordinated Measurement, analysis, and improvement activities (i.e. Client complaint handling, Internal audit, Monitoring and measurement of products and processes, Analysis of data, Control of nonconforming products, Corrective and Preventive Action (CAPA), Failure investigation, Lesson learned implementation, PDCA cycle, Theory of Constraints (TOC), Preparing Spare part list by FMEA, etc.)
  • Review and approval of materials take offs and materials short lists, drawing markups, update master drawing list, Rectified documentation and materials discrepancies with designers and/or manufacturers
  • Perform field and laboratory testing, observation, and inspection of incoming and construction materials (e.g. concrete, steels, piping, bolts, nuts etc.)

Welding Engineer

Confidential

Responsibilities:

  • Dimensional inspections, Reviewed manufacturing data records (MDR), Reviewed material test reports (MTC), Receiving inspection, Weld visual inspection, Blueprint reading, Geometric Dimensioning and Tolerancing (GD&T), Magnetic particle inspection, Liquid penetrant inspection, Hardness testing, Inspection for ferrite content, Positive material identification, Material thickness verification, Pressure test inspection, Paint coating inspection, Prepared technical procedures and reports, Prepared inspection reports, Functional test of equipment

R&D Engineer

Confidential

Responsibilities:

  • Collected and analyzed technical data, prepared technical reports, and prepared technical presentations
  • Participated in supply chain management studies in the Automotive Industry
  • Reviewed and/or approved technical reports
  • Participated in implementation and maintain of quality management system and documents control

Research Assistant

Confidential

Responsibilities:

  • Conducted variety of metallurgical and mechanical tests (i.e. fatigue, tensile, hardness, impact, heat treatment, etc.) on rolling, extrusion, forging, and drawing parts

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