Quality System
- Develop, implement and maintain QMS documentation to maintain compliance with applicable standards such as ISO 9001, ISO 13485 or GMP
- Monitor regulatory changes and update the QMS accordingly
- Conduct internal audits and support external audits (external auditing bodies, suppliers and customers)
- Analyze quality data and metrics to identify trends and areas for improvement
- Collaborate with cross functional teams to ensure that the quality standards are integrated into processes
Management Representative
- Reports on QMS performance to top management and recommend improvement
- Point of contact for certification bodies
- Lead Management Review and follow up action items
Product Quality Management
- Analyze and capture recurring product complaints, collaborate with Operation and Technology teams to address compound specified failures
- Operational Quality Support. To facilitate continuous improvement initiatives, by providing on the floor support through use of quality tools and coaching teams to build ownership and proactive engagement with quality processes.
Customer Complaints Management
- CCAR Manager. Manage the customer complaints handling process to ensure that all complaints are logged with right information for investigation till auditing process
- Collaborate with cross functional team during the investigation, resolution and communication of customer complaints
- Review interim CCAR reports to ensure that root cause is data driven and corrective action(s) address the root cause
Supplier Complaints Management
- SCAR Manager. Approve SCAR - Supplier related complaints and defects, review and monitor the effectiveness of corrective actions
- Collaborate with Procurement, Supplier and internal stakeholders to investigate issues and resolution
- Collaborate with Procurement, Operation and Technology to assess risk and quality impact of raw material on finished goods
Global Quality Team Collaboration
- Support the implementation of global quality initiatives, systems and tools
- Ensure that local QMS aligns with global practices and corporate policies
- Share best practices and lessons learned across global sites
Support Quality Contracts/Documentation
- Review customer documents and quality related agreements for compliances to ensure clauses are relevant, assess the risks.
- Response to customer request for certifications, compliance/quality related/audit documents
System
- Conduct training for staff in Quality Procedure, Standards and Tools.
- Lead processes identified by the Global Quality Team such as PPAP, QIR, CCAR, SCAR and Mastercontrol for the Asia Region
