Role and 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 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
Requirements
Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.
Certificate in Quality Engineering is preferred.
Position requires 4-6 years of quality management experience.
Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations
Able to design quality systems to meet customer expectations and internal needs.
New approaches and continuous improvement must be ongoing.
Results oriented
Customer focus
Decision making
Problem solving
Strategic thinking
Team Leadership
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