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16

quality engineer

  • Manage all customer quality claims and provide objective decisions through data validation and pin point analysis. 
  • Oversee the plant MOC process in compliance with ISO 9001 standard
  • Develop new methods of reporting quality and quality related data.
  • Lead and manage various projects within the processes to help drive down off-quality. 
17

quality engineer

  • Worked as a Quality/Validation Engineer in Design Transfer Team to ensure that the proper device (Insulin delivery device) design is correctly translated into product specifications, by performing Test Method Validation (TMV)
  •  Performed 9 TMV’s for visual inspection measurement system, created fixtures and worked on Test Method Validation for destructive tests. Reviewed Device History Record (DHR) 
  • Prepared Protocols/Reports, documented changes through the change control processes, for accuracy and completeness. 
  • Conducted Gage R&R studies to quantify the robustness of the design. 
  •  Generate statistical analysis using Minitab for setting up production test limits with Six Sigma tolerance. 
  • Responsible for risk analysis, root cause analysis of failures, project quality management and supported CAPA process. 
  •  Ensured compliance with FDA regulation (21 CFR Part 820, ISO 9001 and ISO 13485) for production through validation and verification activities; including developing Test Method Validation, Process Validation, FMEA’s, IQ, OQ and PQs. 
18

quality engineer

  • Oversee the maintenance of associated Database, approved supplier list.
  • Managed 17 supplier corrective & Preventive actions.
  • Conducted effective analysis of failures to determine root cause and implement corrective actions. 
  • Key Functional area: Making of 8d,9d,ICL,PPAP Review etc.
19

quality engineer

  • Do Failure Analysis on rejected units and customer complaints
  • Generates 8D report and facilitates meeting on verified Customer Complaints
  • Verifies jigs and fixtures prior to production use.
  • Verifies effectiveness of Corrective/Preventive actions stated o trouble reports
  • Communicates with Process Engineers with regards to process improvements.
  • Do weekly summary report of Trouble Reports and ensures that all Corrective/Preventive Actions are implemented.
  • Facilitate Calibration of Test and measuring equipment used during production.
20

quality engineer

  • Modify existing software to correct errors, to adapt it to new hardware, or to upgrade interfaces and improve perfo
  • Use microcontrollers to develop control signals, implement control algorithms, or measure process variables, such as temperatures, pressures, or positions.rmance.
  • Determine the quality and reliability standard by studying quality requirements of the products.
  • Performs 5S from time to time.