Fares Elshiekh

ra specialist

• Job Details:Develops and initiates standards and methods for inspection, testing, and evaluation. Assists the quality in developing and maintaining the ISO9001, ISO 13485 procedures and work instructions. Analyzes and resolves work problems, or assists workers in solving work problems. Initiates or suggests plans to motivate workers to achieve work goals. Maintains time and production records. Confers with other supervisors to coordinate activities of individual departments. Interfaces with other departments and the internal trainer to develop and implement training programs as required. Keeps up-to-date with changes in regulatory legislation and guidelines. Monitors and ensures compliance with applicable regulatory requirements, such as FDA regulations, ISO standards (e.g., ISO 13485), and other relevant quality standards. Supports the implementation of risk management processes, including risk assessments, risk control measures, and risk mitigation strategies. Assists in the management of customer complaints, including their investigation, documentation, and resolution. Collaborates with relevant stakeholders to address customer concerns and ensure appropriate corrective actions are taken. Identifies opportunities for process improvement and supports the implementation of quality initiatives to enhance product quality, efficiency, and customer satisfaction. Makes technical files documentation as (risk assessment, instructions for use and clinical evaluation). Reviews and reports overall quality status to the team management.

Quality Assurance Specialist