Designation: Quality Engineer
Qualification: Bachelor’s Degree
- 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