Job overview: Responsible for overseeing Quality Assurance, contributing to strategic planning, and developing and implementing quality systems and control programs to ensure the delivery of high-quality products.
Job description: Develop and establish the overall quality strategy, policy, and objectives for the organization.Implement, maintain, and continuously improve the quality management system.Set quality standards, create associated documentation, and ensure proper control and implementation.Lead the QA team to ensure products meet medical device regulatory requirements, company policies, and customer specifications.Develop and optimize inspection standards for incoming materials, process control, and finished goods.Monitor product performance to ensure conformance to regulatory requirements and specifications.Drive quality improvements based on inspection findings.Approve relevant quality system documents and the closure of nonconformities in the quality system.Oversee the closure of Corrective and Preventive Actions (CAPA) related to product quality.Contribute to, develop, and implement ideas to improve organizational performance.Collaborate with engineering and procurement teams in supplier quality performance management and supplier assessments.Handle internal and external customer complaints, working with customers and quality control teams to resolve quality-related issues.Organize and conduct internal quality audits to ensure compliance.Provide training to the quality department and raise quality awareness throughout the organization.Develop and implement document control programs and coordinate with global customers.Design and implement vendor quality programs.Maintain and enhance quality systems within the organization.Ensure adherence to Health, Safety, and Environmental (HSE) procedures in areas of responsibility.Perform other tasks as assigned by management. Job Requirements: Diploma or Bachelor's degree in Engineering, Science, or a related field.Over 10 years of relevant management experience.Strong expertise in production procedures and quality control.Demonstrated leadership skills and strong business acumen.Familiarity with electronic production processes.Strong data analysis and problem-solving capabilities.Fluency in both written and spoken English.Knowledge of ISO 13485 (current version).High level of responsibility and accountability.Strong personality with excellent communication skillsGood presentation and summary skills.Systematic, global approach to problem-solving.