Quality System Specialist
On-siteChung-ho, Taipei, Taiwan
Job Summary
Manage the implementation, maintenance, and improvement of the Quality Management System, Environmental Management System, and Incident Management System procedures. Lead company-wide internal audits, coordinate external audits with regulatory bodies, and oversee corrective and preventive actions for non-conformances. Direct local ISO activities, control document lifecycles, and serve as the subject matter expert for key QMS elements including CAPA and complaint handling. Gather performance indicators and report status to management while supporting automation projects to optimize system effectiveness. Requires a Bachelor's degree, 2-3 years in quality systems, and knowledge of ISO 9001, 13485, and 14001 standards. Domestic and international travel of 10-20% is required.
Required Qualifications
- Bachelor's degree in related field
- Minimum 2-3 years of relevant experience in quality system
- Experience in developing and leading quality and environmental management system audits in the semiconductor / electronics manufacturing, pharmaceutical or medical device industries
- Working knowledge of ISO International Standards, such as ISO 9001, 13485, 14001, 27001, AS9100, TS16949, etc.
- Influence management skills
- Demonstrated ability to work constructively across all functions of the organization, including with customers and suppliers
- Strong communication and presentations skills (articulate and persuasive)
- Sound organizational and multi-tasking skills
- Strong computer and analytical skills, including data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint, Outlook, etc.
- Knowledge of Risk Management (risk assessment tools such as FMEA, fault tree, etc.)
- Knowledge of KPI (Key Process indicators)
- May require domestic and international travel (10-20%)
Desired Qualifications
- Experience in manufacturing and / or high-tech industry
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