Job Description

Detailed daily activities

  • Review new and modified processes.
  • Analysis for validation or revalidation requirements (IQ/OQ/PQ).
  • Validation protocols creation.
  • Validations tracking.
  • Support on validation corrective actions required.
  • Report validation results.

Statistical support on production processes

  • Required SPC tool evaluation.
  • Report validation results.
  • Capability studies implementation.
  • Gage R&R; implementation.
  • Support to implement methods/altern sampling.
  • Support to eliminate destructive tests.
  • Support to improvement projects.

Job Requirements

Experience

  • Industrial Engineer, Mechanical Engineer, Electronics Engineer, or similar.
  • Medical Industry Experienced.
  • QMS and ISO Standard Knowledge (ISO13485 and/or FDA GMP).
  • Manufacturing Process 3-year-experienced.
  • New Prod...

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