Daniel Martinez

I made validation protocols IQ, OQ, PQ and E.S in order to ensure that the generated protocols comply with the guidelines of ISO-13485, ISO-11607, FDA CFR 21.820, and CFR21.11. With validation results I prepared statistical analysis (CPK, PPK, GR&R and ANOVA among others). Also led training sessions on best practices for executing validation activities with engineering, quality, production, warehouse areas. I investigated equipment failures, identified causes, initiated methods to resolve such issues and developed saving projects for production area.

I was the Supervisor of the Quality Area at the Injection Molding Department where there was 50 lines/machines guiding engineers, inspectors, technicians and other staff. I assured that the control plan of the injection-molding department is fulfilled. Also, I managed and controled the non-conformance product (follow-up and closure of RMED's), follow-up Layered Process Audited and close all corrective actions that apply. I had to assure and comply the IATF 16949/ ISO 140001 current Quality systems.

I gave support in validation of OQ, PQ, IQ, and V.R protocols at the Plastic Molding injection area. I created diagrams illustrating complex processes utilizing specialized CAD software tools like AutoCAD or SolidWorks and also made process capability indices analysis through Minitab.

I Performed internal audits of quality systems and procedures to ensure compliance with ISO 9001 regulations in order to conduct detailed reviews of documents, records, and reports to evaluate effectiveness of quality management system.