Quality Engineer

Designation: Quality Engineer

Location: USA

Qualification: Bachelor’s Degree

Description

  •  Ensure all CAPA requirements are met in each CAPA as part of the approval process.
  •  Escalate identified event, trend, or other input for CAPA consideration.
  •  Ensures overall execution of the CAPA in a timely manner, follows the CAPA Process, and documents and communicates results. This includes:
  •  Coordinating and assigning CAPA failure investigation activities.
  • Documenting the investigation summary and root cause(s) with rationale.
  • Identifying Potential root causes are potential underlying causes for an undesirable condition or problem that has not yet occurred.
  • Coordinating and assigning CAPA implementation activities with an owner and due date.
  • Ensure CAPA reflects up-to-date information
  • Coordinating and assigning CAPA effectiveness monitoring activities with an owner and due date.
  • Conducting to determine assignable cause(s) or root cause(s) of an event or issue associated with a deficiency in a product, process, or quality system that fails to meet established specifications or requirements.
  • Overseeing the CAPA activities to ensure that actions are completed appropriately and with appropriate objective evidence.
  • Identify CAPAs that require periodic review, including risk re-assessment.
  • Provide administrative support to CAPA process. Identify CAPAs that require periodic review, including risk re-assessment.
  • Work with quality sub-system leaders to ensure that data analysis is documented and feeds into the CAPA system.

Bachelor’s degree in Industrial Management or related field

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