Quality Engineer (Cleaning Validation) | HCLTech
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Quality Engineer (Cleaning Validation)

Qualification Required

  • Degree in Microbiology / Biomedical / Mechanical

Roles And Responsibilities

  • Experience in Medical device manufacturing industry.
  • Create/update cleaning process validation protocol/report.
  • Create/update cleaning process work instruction.
  • Experience in Sterilization and chemical residue identification/Acceptance criteria determination.
  • Work independently with the internal and external stakeholders for execution.
  • Candidate must be detail oriented, to review documents with specific (Company/external standards) requirements.
  • 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:

Cleaning validation (Sterilization, chemical residue), 21 CFR820, ISO13485 and ISO14971, Medical Device Quality Management system

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