Marco Sanchez Email and Phone Number

Documentation writing, execution and/or completion of the following:• Development Protocols,• IQ / OQ / PQ Protocols,• Verifications protocols• Validation protocols• Build protocols• Test Method• Computer Software ValidationValidation of:• Process/product• Changes on requirements• Specification changes• Change of components- CO Creation to Create/modify documents such as procedures, processspecifications and Work instructions- Conduct Failure Investigations- Personnel training- Quote and purchase of materials- Calculation of IPQA requirements, Process Control and Finished Goods requirements- Set up and quote for suture chemical properties test (F-TIR Analysis, X-Ray Diffraction, TGA Analysis)- Execution of an IQ, CSV and TMV for a robotic ECNT machine.- Trained QA technicians in the use of the ECNT machine.- Conducted Gage R&R, DOE, Regression Analysis, ANOVA.

Documentation writing, execution and/or completion of the following:• Development Protocols,• IQ / OQ / PQ Protocols,• Verifications protocols• Validation protocols• Build protocols• Test Method• Computer Software ValidationValidation of:• Process/product• Changes on requirements• Specification changes• Change of components- CO Creation to Create/modify documents such as procedures, processspecifications and Work instructions- Conduct Failure Investigations- Personnel training- Quote and purchase of materials- Calculation of IPQA requirements, Process Control and Finished Goods requirements- Set up and quote for suture chemical properties test (F-TIR Analysis, X-Ray Diffraction, TGA Analysis)- Execution of an IQ, CSV and TMV for a robotic ECNT machine.- Trained QA technicians in the use of the ECNT machine.- Conducted Gage R&R, DOE, Regression Analysis, ANOVA.

- Line balance- Scrap reduction- Flow improvement- Time studies- Resources management- One piece flow- Cost reduction projects for consumables in production lines- Kaizen project to reduce walking distance in production lines- Kaizen projects to reduce line space- Kaizen projects to liberate space for new products- Kaizen project for redesign of Kanban.- EHS compliance- VSM change.- Lean Six Sigma certification.Working in the Asset Reconfiguration department with the following responsibilities:- Product transferences- Machines and Equipment relocation (change on layout)Documentation writing, execution end completion of the following:• Project deliverables- Conduct Failure Investigations- Production lines certified by Lean Six-Sigma methodology.- Unification of production lines with savings of 200 square meters and- $70,000.00 Dlls. in savings from equipment and associates.- EHS risks reduction.- 250 simplified work hours for Material Suppliers.

- Line balance- Scrap reduction- Flow improvement- Time studies- Resources management- Plan PPAP study- Design of work stations- Design and implement Pokayokes- Constant communication with different suppliers- Cost reduction projects for consumables in production lines- Lean 3P study- Change of Layout- Design of production line- Implementation of production line- Implementation of new processes- New Product Introduction- Training of associates- Failure investigation through DMAIC methodology- Working in a Product transference project- IQ/OQ- Time studies- Fixture improvements- Weekly updates with Plant ManagerConducted a successful failure investigation following the DMAIC methodology. Presented the results to the Project Director of the company. Such result permitted the introduction of a new production line, and a new product introduction.