1.Quality Management System (QMS) Oversight-Develop, implement, and maintain the QMS in accordance with applicable standards (EN ISO 13485 ).-Ensure QMS processes are effective and continually improve the system.-Oversee the creation, approval, distribution, and management of quality-related documentation.2.Compliance and Auditing-Prepare for and manage external audits and inspections by regulatory authorities and notified bodies.-Assess and manage the quality of… Show more 1.Quality Management System (QMS) Oversight-Develop, implement, and maintain the QMS in accordance with applicable standards (EN ISO 13485 ).-Ensure QMS processes are effective and continually improve the system.-Oversee the creation, approval, distribution, and management of quality-related documentation.2.Compliance and Auditing-Prepare for and manage external audits and inspections by regulatory authorities and notified bodies.-Assess and manage the quality of suppliers and subcontractors.-Conduct supplier audits and ensure that supplier quality standards are met.-Address audit findings and implement corrective and preventive actions (CAPA).3.Product Quality Control-Develop and enforce quality control procedures and testing protocols.-Monitor product quality throughout the lifecycle, from development through production and post-market surveillance.-Oversee the risk management process, including risk assessments and risk mitigation strategies.-Investigate and resolve customer complaints and non-conformities.-Implement actions to address any issues identified and prevent recurrence.4.Regulatory Strategy-Develop and implement regulatory strategies for product approvals, registrations, and compliance.-Stay informed of regulatory changes and assess their impact on the company.5.Regulatory Submissions-Prepare and submit regulatory filings to authorities (e.g., FDA, EMA) for product approvals and market access.-Ensure timely and accurate submission of regulatory documents and responses to regulatory queries.6.Regulatory Compliance-Ensure that products and processes comply with regulatory requirements and standards (MDR).-Monitor and interpret changes in regulations and provide guidance to ensure ongoing compliance.7.Post-Market Surveillance-Monitor and report on post-market surveillance activities to ensure ongoing compliance and safety of the products.-Manage the submission of adverse event reports and field safety corrective actions (FSCAs). Show less

1.Management of the Quality Management System (QMS)-ISO 13485:2016: Oversee and manage the Quality Management System in compliance with ISO 13485:2016, which outlines the requirements for a comprehensive quality management system for the design and manufacture of medical devices.-ISO 17025:2017: Manage the Quality Management System in accordance with ISO 17025:2005, which specifies the general requirements for the competence of testing and calibration laboratories.2.Customer… Show more 1.Management of the Quality Management System (QMS)-ISO 13485:2016: Oversee and manage the Quality Management System in compliance with ISO 13485:2016, which outlines the requirements for a comprehensive quality management system for the design and manufacture of medical devices.-ISO 17025:2017: Manage the Quality Management System in accordance with ISO 17025:2005, which specifies the general requirements for the competence of testing and calibration laboratories.2.Customer Complaints and Associated Actions-Monitor and address customer complaints related to product quality and service. Ensure that complaints are documented, investigated, and resolved promptly.-Implement corrective and preventive actions to address issues identified through customer feedback and improve overall product quality and customer satisfaction.3.Conducting Internal Audits-Plan, execute, and report on internal audits to evaluate the effectiveness of the Quality Management System and ensure compliance with ISO standards and internal procedures.-Identify areas for improvement and recommend actions to enhance the efficiency and effectiveness of the QMS.4.Preparation and Follow-up of Audits-Internal Audits: Prepare for and coordinate internal audits to ensure they are conducted systematically and effectively. Follow up on audit findings to ensure that corrective actions are implemented and verified.-External Audits: Prepare for and support external audits conducted by regulatory bodies, certification organizations, and clients. Ensure that all documentation and records are up-to-date and readily available for review.-Client Audits: Manage and support client audits to ensure that their specific requirements are met and to maintain strong customer relationships through effective communication and resolution of audit-related issues. Show less

1.Management of Change Controls-Coordination and Monitoring: Oversee the coordination, progress, and tracking of Change Controls. This includes reviewing and approving manufacturing documentation (such as fabrication sheets and packaging/labeling files), assisting with initial production runs, managing batch records, analyzing risks, and leading Change Control meetings.-Verification and Approval: Ensure that all change control documentation is accurately verified and approved… Show more 1.Management of Change Controls-Coordination and Monitoring: Oversee the coordination, progress, and tracking of Change Controls. This includes reviewing and approving manufacturing documentation (such as fabrication sheets and packaging/labeling files), assisting with initial production runs, managing batch records, analyzing risks, and leading Change Control meetings.-Verification and Approval: Ensure that all change control documentation is accurately verified and approved. Facilitate the integration of changes into the production process while maintaining compliance with quality standards.2.Project Transfer and Compliance Assurance-Project Transfer: Manage the transfer of projects from the design phase to pilot production and then to full-scale industrialization. Ensure that prototypes (EP - prototype samples) and project samples (EI - project samples) meet preliminary definitions and specifications.-Technical Solutions and Validation: Propose and evaluate different technical solutions for new products. Validate the proposed solutions and contribute to the development of manufacturing processes and control documentation.-Production and Control Documentation: Participate in the creation of manufacturing instructions and control sheets to ensure that new products are produced according to defined requirements and standards. Show less

Final year project with honors. 'Optimization of quality, cost, and lead time performance for the optical fiber division.

Development of decision-making algorithms for managing the stock of tools for a SERDI universal machine.

Study of the performance of a furnace after modification and calculation of the return on investment.

Familiarization with manufacturing procedures and participation in engineering tasks