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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.
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