Senior Quality Assurance Executive

Basic Functions:

1. Assist in maintaining company’s compliance to quality management system established.
2. Responsible in monitoring the calibration and maintenance program.
3. Responsible in internal and external audit program.
4. 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), ISO 9001 are properly implemented and maintained at all levels.
5. Establish and maintain proper document archiving and control system.

Duties:

1. Assist in maintaining company’s compliance to quality management system established.
2. Responsible in internal and external audit program.
3. Assist in handling the corrective and preventive action system and its sub-system (i.e. Nonconforming product and internal audit).
4. Ensure that proper document control procedure and system is implemented for Product Specifications, Operation Manuals, Standards, Drawings and all quality related documents.
5. Co-ordinate, review, collate, update and issue all quality-related documents to relevant personnel.
6. Responsible in calibration and maintenance program
7. Responsible in the equipment validation and process validation.
8. Ensure that all documents submitted and/or generated are archived.
9. Perform other duties as assigned.

Requirements:

Ability to:

1. 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.
2. Establish quality assurance system and undertake systems / product / process validations.

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: 5yrs of relevant experiences. Experiences in ISO 9001 or ISO 13845 is a plus. Certification with lead auditor or internal auditor is a plus.