![MP BIOMEDICALS ASIA PACIFIC PTE. LTD.](https://media.trabajo.org/img/noimg.jpg)
Quality Assurance Executive
4 weeks ago
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.
Tell employers what skills you have
External Audit
Archiving
Quality Management
Quality Assurance
Quality System
Material Qualification
Process Validation
Compliance
ISO 9001
ISO-13485
Audits
Internal Audit
QMS, Quality Management Systems
Terminology
Laboratory
Calibration
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