Quality Systems Manager
Responsible of the CAPA system: investigations, planned deviations, corrections, corrective actions and effectiveness checks.Develop and report quality metrics to division site.Chair the Investigation Review Board.
Responsible of the SAP system Quality Module. Responsible of the Management Review. Responsible of the training area Responsible of the Change Control Area, including validations and procedures changes.Chair the Change Control Review Board.
Direct handling of regulatory audits as a subject matter expert and as a QA representative.
Proficient is six sigma and lean manufacturing tools.