Validation Engineer

3 days ago


San Diego, United States Indotronix Avani Group Full time

Job Summary Validation QE II and SR QE(Validation) :

  • As directed by the Quality Engineering Leader, the Quality Engineer II is accountable validation execution for manufacturing equipment and support in process validation or verification studies.
  • Successful performance requires close work with quality management, operations, suppliers and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.
  • Must demonstrate a working understanding of the ISO 13485 Quality Systems Regulations on Class I/II/II products.
  • Preferred core experience in Quality Assurance, Quality Control, Validation (IQ,OQ,PQ) and Nonconformance management for regulated devices(i.e.: Good Manufacturing Practices, ISO, FDA).
  • Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.

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