Process Quality Engineer

Job Summary Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative. Role and Responsibilities Quality System 1. Develop, implement and maintain QMS documentation to maintain compliance with applicable standards such as ISO 9001, ISO 13485 or GMP 2. Monitor regulatory changes and update the QMS accordingly 3. Conduct internal audits and support external audits (external auditing bodies, suppliers and customers) 4. Analyze quality data and metrics to identify trends and areas for improvement 5. Collaborate with cross functional teams to ensure that the quality standards are integrated into processes Management Representative 1. Reports on QMS performance to top management and recommend improvement 2. Point of contact for certification bodies 3. Lead Management Review and follow up action items Product Quality Management 1. Analyze and capture recurring product com...