Prashant Sawant

Quality Assurance Manager at ABSOLUTE MACHINE MFG INC.
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Location
Toronto, Ontario, Canada, CA
Languages
  • English -
  • Hindi -

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Credentials

  • Certified Quality Technician (CQT)
    ASQ - World Headquarters
    Sep, 2019
    - Sep, 2024
  • ISO 13485:2016 Lead Auditor
    Quality Management International, Inc.
    May, 2017
    - Sep, 2024
  • ZEISS Calypso
    R.G. LOEWENGUTH CO.
    Mar, 2017
    - Sep, 2024
  • Lean Six Sigma Green Belt
    Binghamton University
    Jul, 2015
    - Sep, 2024

Experience

    • Quality Assurance Manager
      • Sep 2021 - Present

      ♦ Manage high production volume customer profiles with a focus on tailoring production approval process (Small PPAP) and control plans. Audit suppliers to ensure quality of components outsourced. ♦ Decrease non conformance rate by more than 50 percent in span of 6 months. Publish monthly reports of COQ. ♦ Help implement, maintain, and sustain ISO 9001 “QMS" along with compliance for automotive standards on some parts. ♦ Train employees lacking knowledge in quality control and perform FAI on CTF/Automotive IATF 16949 Industry parts. ♦ Represent the company in customer meetings to answer SNCR and Supplier corrective action in process. ♦ Close supplier and internal corrective actions for identified non conformance with the time frame. Show less

    • India
    • Appliances, Electrical, and Electronics Manufacturing
    • Project Quality Manager
      • Mar 2020 - Sep 2021

      ◆ Designed custom products and control plans for clients. ◆ Managed custom-process machines for plastic end-use products in the medical field. ◆ Provided consulting solutions for ISO 13485:2016 Quality Management System. ◆ Find root cause for corrective actions and train employees on the discipline required in QC inspections. ◆ Helped to find the root cause for SCAR using 5Y, Ishikawa, and other problem-solving tools. ◆ Managed products in the genre of metal fabrication for the medical industry and Injection molded parts. Show less

    • Quality Engineer
      • Feb 2017 - Feb 2020

      Quality Engineer Lead with a focus on qualifying medical products in the Injection Molding industry to confirm if they are ready for production or not, by finding the most optimal process for molding. Lead auditor Experience in helping the company certify for ISO 13485. ◆ Facilitated and perform IQ / OQ / PQ validation procedures to qualify a medical product. ◆ Find an optimal process reviewing data collected from high/low processes determined using the DOE study. ◆ Set inspection methods, Control plan, and Work Instruction by creating Zeiss, Micro VU& Vertex programs. ◆ Maintained the Quality Management system by training employees to follow and perform Internal Audits as per ISO 13485:2016 and 21CFR 820 FDA. ◆ Created COQ to estimate total failure cost as per data available every week from Non-Conformance and RMA. ◆ Created Trend analysis to analyze data as per different departments, machines, Cells, Customers and products. ◆ Closed CAR, IACAR, and SCAR by implementing requested action items in a timely manner by finding the root cause. ◆ Qualified and maintain the product to make sure it satisfies customer requirements and solve product-related issues. ◆ Acted as a Customer representative being the prime contact to resolve any concerns and provide information. ◆ Do research and development required to qualify a product during the prototype phase. ◆ Determined melt flow index, 6-step study to determine a better process. ◆ Created CPK graphs and trend analysis using data collected from 5-hour runs to confirm if the CPK value is higher than 1.33 ◆ Organized APQP meetings at the start of the project and AAR meetings at the end of the project. Managed a team of sixteen members. ◆ Maintained DHR for medical devices and train employees in risk management complying with ISO 14971. Show less

    • United States
    • IT Services and IT Consulting
    • 1 - 100 Employee
    • Quality Engineer
      • Jun 2016 - Jan 2017

      Deliver optimal support to develop and evaluate the process capability, process control plans, analysis of out-of-control conditions, and process audits with the objective of improving the process performance and capability. Proficiently leverage an understanding of AS9100 standards for compliance management in manufacturing and production environments. Perform internal audits ensuring AS9100 standards are maintained. ♦ Collaborated with QA leadership and support analytical qualification of production equipment, while working with quality inspectors to inspect parts, conduct research to qualify new and existing devices, equipment and systems. ♦ Aligned with internal/external resources to improve manufacturing processes and achieve organizational goals; facilitate investigation and eliminate root causes of quality problems by implementing corrective actions. ♦ Adhered to AQL standards while collecting data from CMM to create line reports while following various AQL plans provided by customers. ♦ Successfully reduce the major and minors for CB audit. ♦ Instrumental in authoring monthly PPM using DMR to find a pattern of defects and to improve Quality Processes; evaluated material certificates to meet customer specifications and created SCAR as required. ♦ Possess knowledge for utilizing a Comparator and CMM inspection machine along with the CMM manager. ♦ Completed First article Inspection Report in accordance with AS9100 and Final Inspection reports to ensure all required characteristics and features were communicated. ♦ Created Delta Fair in case of Rev change for new specification by making sure all documents are updated. ♦ Leveraged statistical analysis skills to calculate mean, STDEV, CPK and created control charts from the inspected data sheets and utilized DMAIC, 5 Why’s to make corrective actions. ♦ Create PPAP for the critical parts ensuring they have FMEA , process control plans, final part inspections reports, drawings and process flow charts. Show less

    • Machinery Manufacturing
    • Production and Supply Chain Analyst
      • Apr 2014 - Dec 2014

      • Decided which parts should go on which machines to reduce cycle time using Job shop scheduling. • Handled procurement of raw material in the workshop, also made decisions to improve quality, efficiency, productivity of operations which enhanced overall profitability • Made decisions on which part has to be outsourced for cost effectiveness, time and then handle the supply chain. • Negotiated pricing with vendors by personally meeting them and finding out points of common interest for profit of both, selected suppliers on basis of required parameters such as responsiveness, low cost and quality at same time. • Coordinated with clients for modification in drawing, design in various phases of manufacturing. Show less

    • United States
    • Machinery Manufacturing
    • 1 - 100 Employee
    • Production Engineer - Intern
      • Dec 2013 - Apr 2014

      • Acquired an understanding on which parts would best fit on which machine as per requirement, to reduce cycle time and reduce cost involved in setting up fixtures. • Analyzed blueprints, drawings, process sheet and implemented the setup operation for parts. • Interpreted specifications, drawings, job order for employee and assign duties accordingly. • Acquired an understanding on which parts would best fit on which machine as per requirement, to reduce cycle time and reduce cost involved in setting up fixtures. • Analyzed blueprints, drawings, process sheet and implemented the setup operation for parts. • Interpreted specifications, drawings, job order for employee and assign duties accordingly.

    • Machinery Manufacturing
    • 1 - 100 Employee
    • Production Supervisor
      • May 2013 - Nov 2013

      • Supervised crane assembly for Grab Bucket, Gantry and E.O.T Cranes. • Understood manufacturing and assembly of girder and trolley as per required load in Tons. • Recognized what job order and duties should be assigned to employees as per skills of employee and time slot available, solved problems faced by employees during assembly. • Supervised crane assembly for Grab Bucket, Gantry and E.O.T Cranes. • Understood manufacturing and assembly of girder and trolley as per required load in Tons. • Recognized what job order and duties should be assigned to employees as per skills of employee and time slot available, solved problems faced by employees during assembly.

Education

  • Northeastern University
    Masters, Project Management
    2021 - 2022
  • Binghamton University
    Masters, Industrial and Systems Engineering
    2015 - 2016
  • University of Mumbai
    Bachelor's degree, Mechanical Engineering

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