Basic Functions:
- Assist in maintaining company’s compliance to quality management system established.
- Responsible in monitoring the calibration and maintenance program.
- Ensure that ISO 13485, In-vitro Diagnostics Directive 98/79/EC, IVDR 2017/746 and 21 CFR Part 820 Quality System Requirement, MDSAP (Medical device Single Audit Program) are properly implemented and maintained at all levels.
- Establish and maintain proper document archiving and control system.
Duties:
- Assist in maintaining company’s compliance to quality management system established.
- Assists in internal and external audits.
- Responsible in handling the corrective and preventive action system and its sub-system (i.e. Nonconforming product and internal audit).
- Ensure that proper document control procedure and system is implemented for Product Specifications, Operation Manuals, Standards, Drawings and all quality related documents.
- Control and compile Production / QC Master Batch Records and ensure that the Quality Records Master List is updated. Together with the Documentation Center, ensure that all documents submitted and/or generated are archived.
- Co-ordinate, review, collate, update and issue all quality-related documents to relevant personnel.
- Prepare necessary documentation (e.g. Certificate of Analysis and Certificates of Origin) to support shipment of products overseas.
- Control and compile Production / QC Master Batch Records and ensure that the Quality Records Master List is updated. Ensure that all documents submitted and/or generated are archived.
- Receive Production / QC Records and all quality related documents and ensure that proper document archiving and control system is implemented.
- Ensure that all documents submitted and/or generated are archived.
- Compile and ensure that the Quality Records Master List is updated.
- Perform other duties as assigned.
- Support the projects of material qualification
- Any other duties as and when assigned.
Minimum qualification Requirements
Ability to:
- Demonstrate the use of all equipment, materials, and techniques relevant to job performance, execute and maintain pertinent validation protocols as required and maintain quality standards.
- Establish quality assurance system and undertake systems / product / process validation
Knowledge of: Various quality control/process control requirements, quality management system and documentation relating to biomedical and /or IVD products. Technical terminology used in the laboratory, assigned scientific techniques and knowledge of QC procedures governing a number or basic laboratory operations.
Education: Basic Science Degree
Experience: No prior working experience is required for Executive position. At least 3 years of relevant working experience for Senior Executive position.
