Roles & Responsibilities
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 improvementPoint of contact for certification bodiesLead Management Review and follow up action itemsProduct Quality Management
Analyze and capture recurring product complaints, collaborate with Operation and Technology teams to address compound specified failuresOperational 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 processCollaborate with cross functional team during the investigation, resolution and communication of customer complaintsReview interim CCAR reports to ensure that root cause is data driven and corrective action(s) address the root causeSupplier Complaints Management
SCAR Manager. Approve SCAR – Supplier related complaints and defects, review and monitor the effectiveness of corrective actionsCollaborate with Procurement, Supplier and internal stakeholders to investigate issues and resolutionCollaborate with Procurement, Operation and Technology to assess risk and quality impact of raw material on finished goodsGlobal Quality Team Collaboration
Support the implementation of global quality initiatives, systems and toolsEnsure that local QMS aligns with global practices and corporate policiesShare best practices and lessons learned across global sitesSupport 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 documentsSystem
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 RegionTell employers what skills you have
Coaching
Team Collaboration
Quality Management
Quality Assurance
Quality System
ISO
GMP
Investigation
Auditing
Procurement
Compliance
ISO 9001
Quality Engineering
Audits
PPAP
Manufacturing