Quality System Associate

Role Responsibilities

• Serve as the central point of contact and oversee all customer product quality complaint activities, including managing complaint investigation report numbering.
• Acknowledge and respond to customer complaints within defined timelines, utilizing Complaint Investigation Reports (CIR), CAPAs, or other applicable methods.
• Coordinate initial investigations through batch reviews and retained sample testing, issuing Corrective/Preventive Actions (CAPA) to relevant departments as necessary.
• Maintain and update the customer complaint log, preparing reports on trend analysis.
• Ensure monthly updates of complaint data and conduct quarterly and yearly trend analyses for management review. Yearly complaint trend analysis for management review activities.
• Manage all CAPA activities across multiple sites from initiation to closure.
• Follow up with responsible personnel on CAPA progress stemming from customer complaints, external audits, and internal audit findings.
• Maintain the CAPA log and prepare reports on trend analysis.
• Update monthly CAPA data and conduct yearly trend analyses for management review.
• Act as Document Control Coordinator (DCC) as needed.
• Publish and distribute DMS-related documentation.
• Support other Group QA QMS activities as required.
• Perform all other duties and tasks as assigned by superior.

Role Requirements

• Must posses at least a Bachelor Degree in Science or any related discipline.
• Fresh graduates or minimum 2 years QA experience in relevant manufacturing industries such as medical devices or pharmaceutical will be of advantage.
• Knowledge of quality management systems (e.g. ISO 13485) in document control, complaint handling and continuous improvement.
• Good oral and written communication in English and Bahasa Malaysia.
• Familiar with Excel, Words and Power Point.
• Familiar with document management system handling with strong continuous improvement mindset.
• Highly competitive and self-motivated.
• Good communication skills with a good working attitude.
• Disciplined and able to work independently.