Quality Engineer (Morrisville)

Are you an experienced Quality Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Quality Engineer to work at their company in Morrisville, NC.

Primary Responsibilities / Accountabilities :

• Work independently to initiate, investigate and support quality Events, Complaints and CAPA's and SCARS.
• Coordinate and maintain customer complaint & CAPA management system, validations for all departments, along with the Calibration Program and the Environmental Monitoring Program.
• Write and implement methods and procedures for supporting the quality management system.
• Review and approve quality assurance procedures and reports.
• Coordinate the implementation of process controls to support manufacturing operations.
• Review and approve methods and procedures for supporting the quality management system.
• Support the implementation of client's Business Solutions (ABS) initiatives.
• Participate in the investigation, resolution, and prevention of product and process non-conformances.
• Provide support for validations.
• Facilitate audits (both internal and supplier) and support compliance with applicable Regulatory Quality System standards.
• Participate in supporting quality decisions.
• Support, coordinate and maintain service provider qualification and monitoring.
• Conduct root cause analysis investigation and perform risk assessment and evaluations to identify appropriate corrective action.
• Conduct quality assurance tests and perform statistical analysis to assess the level of control and manage product quality risks.
• Employ Quality Engineering tools and techniques to develop, align and optimize systems and processes.
• Participate and support Tier Daily Management
• Write reports and facilitate its use for supporting the quality management system.
• Support service provider qualification and monitoring.
• Ensures the cleanliness of work areas.
• Performs other duties as assigned by the Manager.
• Follows applicable safety procedures.

Qualifications :

Preferred :