MANAGER - QUALITY ASSURANCE, COMPLAINT HANDLING

Job Description

OVERVIEW

• To manage external and internal complaints in a timely manner and to maintain complaint files as per quality standard, customers and regulatory requirements.
• To assist in development, maintenance and management of complaint handling procedures.
• To provide training and guidance to subordinates.

DUTIES AND RESPONSIBILITIES

Business / Operations

• Monitoring and controlling resources and overseeing the spending of money within budget 
• Implementing policies, standards, and procedures for complaint handling
• Managing customers complaints and developing corrective actions and preventive actions (CAPA)
• Developing and implementing audit plans that adhered to both internal policies and regulatory/industry compliance requirements
• Leading and facilitating customer/external audit on company products, processes and Quality Management System (QMS)
• Identifying opportunities and recommending projects to drive continuous process improvements
• Preparing technical reports summarizing findings and corrective actions.
• Lead quality improvement projects within the quality management system by monitoring and reviewing the projects progress; and establish strategy to ensure project completion and objectives met within the timeline set.
• Lead and facilitate activities related to customer complaints and shipment failure.
  • Manage and monitor the resolution of customer complaints and shipment failure, within given timeframe.
  • Enforce and ensure effective implementation of the CAPA system to prevent the reoccurrence of any non-conformities relating to customer complaints and shipment failures.
  • Oversee the handling of customer complaints and shipment failures by providing advice and support to staff on handling of complaints (external and internal), on investigation techniques and carrying out root cause analysis and writing report.
  • Ensure review of replies / feedback to customer complaints prior to final approval by superior.
  • Ensure all policies and procedures relating to customer complaints are followed and are adhered and documented.
• Maintenance of complaint management system and promote improvement within the organization.
  • Ensure complaint handling procedures are reviewed and updated to ensure its accuracy, suitability and effectiveness.

People / Stakeholder Management

• Leading a team of engineers, and executives preferably for a medium to large-scale manufacturing organization
• Navigating multiple stakeholders within the organization to achieve results 
• Building cooperative working relationships within the organization
• Building enduring relationships with key customers

REQUIREMENTS

• Bachelor Degree in relevant field.
• Minimum 8 years of working experience in quality audit roles and manufacturing environment.
• Preferably in medical devices industry.
• Good Manufacturing Practices (GMP) 
• Quality Management System (QMS) and operating practices
• Manufacturing processes and operations
• Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA) and problem-solving techniques
• Project management principles
• Work planning and scheduling

Certification / License Requirement:

• Lead Auditor Certificate / ISO 13485 Process Based Auditing Certificate.