Develop and support a comprehensive, enterprise wide, Quality Management System compliant with ISO 9001:2008. Focus on QMS documentation and refining quality controls, including leading Corrective and Preventive Action (CAPA) efforts, supplier qualifications, and requirements compliance. Support released products, evaluate returns, and establish incoming inspection and in-process inspections where required. This is a developmental opportunity for the right candidate.
Leads activities in the development and maintenance of an ISO 9001:2008 compliant Quality Management System.
Supports continuous improvement initiatives, including the implementation of quality plans and procedures that drive quality improvements. Coordinates resolution of quality issues, and raises concerns to quality management, as appropriate.
Assumes lead role in supplier development by conducting quality audits and developing subsequent preventive action programs, including an approval/rating program through the exercise of rigorous qualification processes.
Coordinates inspection related activities in support of other departments’ functions and requirements.
Reviews, analyzes and reports on quality discrepancies and CRL quality goals.
Manages the CAPA System ensuring CAPA’s are evaluated and closed in an expeditious manner, including actions on returns or product complaints.
Identifies non-conforming materials and workmanship, performs root cause analysis, and implements effective short and long-term corrective actions.
Coordinates the reporting, analysis, and resolution of non-conformance incidences including active participation in Material Review Board and other meetings as needed.