Manager of Quality Systems with experience in all quality related fields for over twelve (12) years. Strong experience in CAPA systems and successfully implemented a CAPA certification program in Jayuya with demonstrated results reducing investigations timeline and leveling up the compliance at the same time. In charge of the training program and the validations overview. Implemented QM module in SAP for Abbott Jayuya. In charge of the documents change control system acting as a liaison between the Plant and the Division Change Control Area. A leader with a genuine quality attitude with proven ability to: promote a safe and motivating compliance environment; encouraging a culture that supports continuous improvement and employee’s participation; develop an atmosphere that promotes open communication with colleagues. Strong experience with regulatory agencies with an excellent history of compliance. Proven ability to optimize both profit and compliance standing within the portrait of the company’s mission, vision and values
Apr 2008 - Present
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.