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Manufacturing Engineer

Company: HCL Technologies
Location: Warsaw
Posted on: June 23, 2022

Job Description:

  • Develop and execute all the Process Validation deliverables / activities which include IQ, OQ, PQ, SOP, Validation Plan, Functional Requirement Specifications (FRS), User Requirement Specifications (URS), Requirement Traceability Matrix (RTM) and summary reports.
  • Perform capability analysis (Cpk, Ppk) on test data, investigate outliers and work on sampling plans (Minitab).
  • Perform Design Of Experiments (DOE) to determine sampling plans.
  • Develop Test Method Validations (TMV's) using the principle of Gauge R&R, testing methodologies
  • Collaborate with cross functional teams for various projects following Quality Management systems in compliance with ISO 13485, 21 CFR 820,
  • Utilize fundamental Engineering to apply Lean, Kaizen and Six Sigma in the improvement process.
  • Prepare detailed project plans with breakdown of all activities, milestones, efforts, and timeline in concurrence with project members & stakeholders
  • Monitor and evaluate project resource needs ensuring the continuity of project and timely communication to stakeholders
  • Track project milestones, organize weekly governance meetings, and provide regular status reports

Keywords: HCL Technologies, South Bend , Manufacturing Engineer, Engineering , Warsaw, Indiana

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