Job Description

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.

• 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 skills
• Good presentation and summary skills.
• Systematic, global approach to problem-solving.