Luisana Sanchez Email & Phone Number

Tijuana, Baja California, México

• Participated in the development, implementation, and maintenance of the Quality Management System.• Generate appropriate documentation and assistance to support an FDA 510(k) approval.• Full participation in Risk Management activities, including hazard analysis, risk assessments and risk mitigation.• Assist in the identification, development and implementation of corrective and preventive actions (CAPA) to improve overall quality results.

Tijuana Area, Mexico

• Plan, coordinate and execute process validations through the IQ, OQ & PQ phases whenintroducing or changing manufacturing processes or equipment.• Lead design reviews to ensure product effectiveness and process development.• Generate validation documentation such as Master Validation Plan, Protocol,Validation Report, Test Report and Test Indecent Report.• Responsible for ensuring the technical, economic, regulatory and product design viability, involving all relevant stakeholders.

Tijuana Y Alrededores, México

• Managing the manufacturing of two product families which represents the 60% of the overall company’s business.• Lead a manufacturing staff, including 60 direct collaborators and four group leaders, while implementing changes therefore gain leadership and people skills.• Solving manufacturing problems in the production line, ensuring product and process quality by analyzing and planning workflow, space requirements, and equipment layout.• Manufacturing and Design Changes application through ECN’s, creation and updating ofStandard Operational Procedures (SOP’s), Manufacturing Manuals (MF’s), Job Instructions(JI) and Production Forms (FM’s)to make improvements to current operations to enhanceefficiency.