Senior Quality Assurance Executive
3 weeks ago
Basic Functions:
- Assist in maintaining company's compliance to quality management system established.
- Responsible in monitoring the calibration and maintenance program.
- Responsible in internal and external audit 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), ISO 9001 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.
- Responsible in internal and external audit program.
- Assist 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.
- Co-ordinate, review, collate, update and issue all quality-related documents to relevant personnel.
- Responsible in calibration and maintenance program
- Responsible in the equipment validation and process validation.
- Ensure that all documents submitted and/or generated are archived.
- Perform other duties as assigned.
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 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.
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