Quality Engineer

Indiana
Posted 2 weeks ago

Job Description:

  • Assure compliance with FDA Quality Systems Regulation, ISO Standards and SOP’s
  • Apply Quality Engineering techniques on new and/or existing products.  Assure all products meet or exceed customer requirements.
  • Support product teams in the implementation of Lean/Cost Saving Initiatives.
  • Represent Quality in production process efforts, quality planning, FMEA and Risk Analysis.
  • Participate in IQ/OQ/PQ validation activities including the drafting, review and execution of protocols.
  • Apply statistical tools such as Process Capability, Measurement System Analysis and Statistical Process Control to assess and improve production processes.
  • Handle customer complaints including the implementation of problem-solving actions to ensure product quality. Maintain all required documentation for closure.
  • Work with departments to assure thorough Corrective Action problem-solving implementation.
  • Review product and process changes to ensure proper documentation and actions related to risk assessment are completed.
  • Train Quality Assurance Inspectors and manufacturing personnel in understanding specifications, new product, procedures and measurement techniques.

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