Job Description

Summary This position is responsible for managing the activities and procedures associated with complaints. He/she is accountable for setting own work direction and completing work tasks which include the following- effective and timely processing of customer complaints including maintenance of complaint files, liaison with Business/ Customers/ Manufacturers, responses to customers and Complaint Quality reports; perform review of Adverse Events (injury complaints) for reportability to regulatory authorities; review and evaluate service complaint cases and work orders to determine if the information received meets the criteria for a product complaint and categorize the cases into complaint and non-complaint. This position is also responsible for continuously support the needs of the business and its customers


II. Key Responsibilities

• Responsible for the management of the complaint handling process and the review of service complaint cases and work orders as assigned. Activities include:
  Review all Customer complaints about validity and assures complaints are processed in compliance with Company policies and procedures.
  Communicate and partner with the business team and technical team in customer management
  Complaint and non-complaint tracking and escalation management
  Implement and follow procedures to ensure timely and accurate receipt and review of service complaint and non-complaint cases and work orders.
  Implement and follow procedures to ensure timely and accurate receipt, logging, analysis, and response to customer complaints.

• Ensure the Customer complaint investigation, procedures, and activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance.
• Provide training to personnel involved in complaint investigation and complaint systems (such as Trackwise, Salesforce, Service-Max, etc) users, as a directive by the Supervisor.
• Perform review of Adverse Events (injury complaints) for reportability to regulatory authorities for multiple countries according to BD procedures.
• Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering the course of action when and where necessary.
• Remain current in any upgrades to complaint handling systems.
• Ensure that the Service Level Agreement (SLA) metrics are met.
• Comply with all ISO 13485 requirements and BD policies.
• Ensure a safe, healthy and environmentally friendly workplace by observing Company\xe2\x80\x99s rules and procedures. Active involvement in prevention, elimination of potential safety hazards and participation in activities which promotes recycling, replacement, and reduction of resource materials.
• Executes any tasks and/or projects as assigned by the Supervisor and/or higher management.

III. Education

• Diploma or BS Degree desired, preferably in scientific, technical or engineering discipline, or applicable work experience

IV. Other Qualifications - Professional Certification/Key Licenses

• Relevant quality assurance experience in quality systems for complaint management, failure investigation, corrective & preventive action, and document & quality records management.

V. Experience

• Working experience in the pharmaceutical or medical device manufacturing industry is preferred.

VI. Required Knowledge and Skills

• Working knowledge of Quality System standards and regulations ISO 9000:2008, ISO 13485: 2016 or US FDA QSR (21 CFR 803 & 820) will be an advantage.
• Fluent in spoken and written English.
• Good communication skills. Must be able to communicate precisely and accurately to all levels of the organization.
• Continuous and versatile learning.
• Drive for results and action oriented with a high sense of urgency.
• Self-starter with the desire and ability to take initiative.
• Demonstrated ability to work independently under time constraints, manage competing priorities and deadlines, and handle multiple tasks efficiently and effectively.
• Must be able to identify and resolve problems and requests in a proactive and timely manner.
• Must be able to gather and analyse information skilfully using problem-solving/root cause analysis skills.
• Ability to exchange information clearly and concisely.
• Ability to work for a large, fast-paced, matrix organization with speed and accuracy.
• Ability to work well in a team-oriented environment.
• Able to use Microsoft Excel spreadsheet with knowledge of formulas, statistical and modeling tools to identify and improve processes
• Proficiency in statistical analysis and metrics reporting and associated tools and packages
• Able to use PowerPoint skills for the creation/maintenance of organization charts and presentations.
• Provide support to Customer Facing Teams

Primary Work Location MYS Kuala Lumpur - Jalan Kerinchi

Additional Locations

Work Shift MY1 Standard (Malaysia)