Senior Quality Engineer

1 day ago

Bengaluru, Karnataka, India SMC Ltd Full time ₹ 4,20,000 - ₹ 12,60,000 per year
  • Working knowledge of various metrology devices like Vision Measurement System (VMS), Co-ordinate Measuring Machine (CMM), Vernier Caliper, Micrometer, Comparator, Height Gauge, etc.
  • Develop and establish quality procedures & shift schedules for inspectors for testing of products in all stages of manufacturing.
  • Review product drawings, classify all the probable nonconformities into various risk categories & define a control plan (inspection & lab test methods & sampling frequency, sample size & AQL) for all.
  • Interact with engineering function on FMEA & inspect & review engineering releases, adhering to strict guidelines on quality risk management methods.
  • Perform process audits, product audits & internal quality audits and report the findings.
  • Maintain a CAPA log record, follow up on open CAPAs, and update.
  • Train quality engineers, inspectors & operators on updated work instructions & quality control methods and guide them on measurement (metrology) methods.
  • Work with the production team to implement testing criteria or assembly methods developed.
  • Organize incoming inspection of raw materials & bought-out parts, an in-process inspection of items & final inspections of finished products as per defined frequencies. Conduct supplier audits, and monitor supplier quality performance & corrective actions if any.
  • Monitor cleanroom conditions by organizing external testing as per AHU re-qualification procedures.
  • Maintain the list of monitoring and measuring devices, schedule & organize periodical calibration.
  • Facilitate successful qualification/validation of processes in product development (IQ, OQ, & PQ), record the results & document them as applicable & as defined by the customer for all the phases.
  • Perform gauge R&R, process capability studies, etc. to meet quality deliverables.
  • Identify & retain customer-approved samples, control samples & defect limit samples if any.
  • Oversee cleanroom activities by daily rounds to ensure that the production & assembly processes adhere to the planned controls and critical process parameters.
  • Compile all the documents into respective Device Master Records.
  • Review and maintain the inspection logs production and quality records daily.
  • Review the Device History Files (DHF - for defect incidences, if any) & make certificates of analysis /or conformity to recommend product releases.
  • Organize to collect samples, check for visual (physical) defects, e.g. color, texture & strength & locate imperfections; measure control dimensions.
  • Periodically monitor, review & update the inspection & testing procedures, improvement is required.
  • Find the root causes of defects & develop creative solutions using problem-solving techniques.
  • Provide timely feedback to engineering & production regarding product non-conformity & ensure timely disposition of non-conforming products and closure of NCMRs.
  • Ensure that changes & deviations, if any, are documented and are approved prior to implementation.
  • Perform the tasks as may be required from time to time as assigned by the management.
  • Strong attention to detail & documentation & the ability to provide professional & technical support.
IND

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