Quality Engineer (Medical Device Industry) | HCLTech
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Quality Engineer (Medical Device Industry)

Qualification Required

  • Degree in Mechanical, Materials or Biomedical Engineering with years of experience

Roles And Responsibilities

  • Hands on experience in Test Method Validation (TMV)
  • Hands on experience in Manufacturing related CAPA Activities
  • Hands on experience in Production Non-conformance (NCMR's)
  • Working independently with the internal and external stakeholders for execution.
  • Provides Quality Engineering support for commercial Medical products.
  • Ensures changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.
  • Utilizes quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
  • Navigates complex government regulations to include FDA & QSR requirements and guidance under 21 CFR820, ISO13485 and ISO14971.Present technical data to groups within and outside the organization

Required Technical And Professional Expertise: Medical Device, Quality, TMV (Test Method Validation), CAPA, NCMR, ISO13485.

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