• Preparation of validation protocols and final reports for sterilization processes.• Preparation of protocols and final reports to adopt new products.• Participation in validation activities on a level to make it possible to review/approve the documents related to the activities such as validation reports.• Provide support in connection with product registrations and/or inquiries from authorities and customers, and customer audits.• Involvement on Supplier evaluation activities related to sterilization projects.• Monitor the process output and organize activities to meet and maintain the product quality standards.• Participate on internal and external sterilization/production site audits.• Participate in development teams having as main responsibility the quality and fulfillment with the regulations or other applicable standards.• Support to update and develop Sterilization PFMEcA from the Risk management.• Participate in projects to support sterilization, sterility assurance, contamination controls projects.• Preparation of samples to sterilization projects and coordination of tests with external laboratories.• Create CCR for sterilization projects.• Communication with external laboratories, request quotes, follow up to create P.O to comply with the company quality policy.

• Conduct and manage problem solving sessions. Plan, schedule, conduct and coordinate work phases in quality engineering projects.• Create and implement changes to validation and change control programs to improve compliance, reduce costs and improve customer service.• Develop quality plans during the transfer of new products including raw material, process specifications and final product specifications, qualification and test methods, supplier capability analysis, validation strategies and product design and reliability.• Provide support to the process mapping and process validation area ensuring that they are in compliance with ConvaTec's global validation process and guidelines.• Ensure compliance with quality standards in all phases of validations of new and transferred equipment, methods and / or products. • Develop, validate and transfer test methods for new and existing products and processes.• Create Quality Control Plans.• Lead, Plan, schedule and coordinate the phases of the manufacturing quality engineering projects to improve the Overall Equipment Efficiency of the WorkCentre's through the usage of Lean, Six sigma methods.• Apply quality engineering tools and techniques during the different phases of the product and process validation, product development, products and processes transfer, transfer designs, process and product changes.• Perform risk assessments for new and transfer products.• Ensure the implementation under compliance for new products and processes development, products and processes transfers and products and processes changes.• Create and implement changes in the Validation and Change Control programs to improve compliance, reduce costs and improve customer service.• Validate manufacturing controlled areas (Clean Rooms and White Rooms).

• Ensure compliance with quality standards in all phases of validations of new and transferred equipment, methods and / or products.• Develop, validate and transfer test methods for new and existing products and processes.• Create Quality Control Plans.• Lead, Plan, schedule and coordinate the phases of the manufacturing quality engineering projects to improve the Overall Equipment Efficiency of the WorkCentre's through the usage of Lean, Six sigma methods.• Apply quality engineering tools and techniques during the different phases of the product and process validation, product development, products and processes transfer, transfer designs, process and product changes.• Perform risk assessments for new and transfer products.• Ensure the implementation under compliance for new products and processes development, products and processes transfers and products and processes changes.• Create and implement changes in the Validation and Change Control programs to improve compliance, reduce costs and improve customer service.• Validate manufacturing controlled areas (Clean Rooms and White Rooms).

• Ensure compliance with quality standards in all phases of validations of new and transferred equipment, methods and / or products.• Develop, validate and transfer test methods for new and existing products and processes. • Create Quality Control Plans.• Lead, Plan, schedule and coordinate the phases of the manufacturing quality engineering projects to improve the Overall Equipment Efficiency of the WorkCentre's through the usage of Lean, Six sigma methods. • Apply quality engineering tools and techniques during the different phases of the product and process validation, product development, products and processes transfer, transfer designs, process and product changes. • Perform risk assessments for new and transfer products. • Ensure the implementation under compliance for new products and processes development, products and processes transfers and products and processes changes. • Create and implement changes in the Validation and Change Control programs to improve compliance, reduce costs and improve customer service.• Validate manufacturing controlled areas (Clean Rooms and White Rooms).

• Guarantee a smooth transition from the process development phase to the positive manufacturing performance, ensuring compliance with regulatory and safety procedure.• Identify opportunities to improve the Overall Equipment Efficiency of WorkCentre.• Validate manufacturing controlled areas (Clean Rooms and White Rooms).• Bill of materials creation (BOM). • Job aids and visual aids creation. • Work instructions creation. • Analyse and resolve complex manufacturing and regulatory problems (CAPA, Non Conformity, audit observations).• Write validation protocols (MVP, ESR, IQP/IQR, OQP/OQR, PQP/PQR, MVR) to qualify and validate manufacturing processes. • Execute validations protocols required to operate in the medical devices industry (ESR, IQ, OQ, PQ).• Perform machine EHS assessments to ensure safety and proper operations.

• Bill of Materials (BOM) creation/update as part of project implementations.• Work instructions creation. • Visual aids creation. • Packaging and labeling, device specification, process instruction and sub-assembly creation. • Validation support of Controlled Manufacturing Environments.• Time study execution. • Manufacturing lines personnel training.• Controlled documentation improvements.• EHS and 5S internal audits.• Support Project Engineers on validation stages such as Engineering Studies, Installation Qualifications, Operational Qualifications and Performance Qualifications.

- Selling opportunities updating for Service staff, project and Energetic Efficiency Department.- Service’s Orders reports control.- Customer Satisfaction Surveys on SAP.- Service’s KPIs monitoring, etc.