OVERVIEW
Manage external and internal complaints in a timely manner and maintain complaint files as per quality standards, customers, and regulatory requirements.
Assist in the development, maintenance, and management of complaint handling procedures. Leading, coaching, and guiding a team (subordinates).
DUTIES & RESPONSIBILITIES
Focus on customer satisfaction in quality area including the effectiveness and responsiveness of problem solving that meeting the customer expectations.
Review customer complaint report and provide response to the customer.
Lead and facilitate customer visit that involves the review of committed complaint CAPA action plan.
Support the customer or external audit on company products, processes and Quality Management System (QMS).
Resolve customer issue by driving Root Cause Analysis (RCA), corrective and prevention action plans for the reduction of shipment failure and customer complaints.
Work with cross functional team and stakeholders to identify opportunities or recommend quality projects to drive continuous process improvement.
Review process, resource spent and KPI achievement.
Coach and build a strong QA Complaint Management Team with quality and customer-centric culture.
Manage staff' performance and development.
REQUIREMENTS
Bachelor's Degree in Science/ Engineering or any related discipline.
At least 8 year(s) of working experience in Quality Assurance.
Lead Auditor Certificate / ISO 13485 Process-Based Auditing Certificate will be added advantage.
Knowledge in Good Manufacturing Practices (GMP), Quality Management System (QMS) and operating practices.
Knowledge in Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA) and problem-solving techniques
Complaint Handling Procedures.
Familiar with the standards such as ISO9001, ISO 13485, MDSAP, HACCP etc.#J-18808-Ljbffr