Engineering Executive / Officer - Rapid Progression

Competency Requirements:

1. Minimum Diploma, Degree or any equivalence required.
2. Good in time management and problem-solving skills.
3. Document controlling knowledge.
4. Basic Auto CAD knowledge.
5. Good in communication and team working skills.
6. Hard working and consistence in completing tasks according to schedule.
7. Positive attitude towards work and changes in work environment. 

Responsibility:

1. Design validation study features, such as sampling, testing, or analytical methodologies.
2. Direct validation activities, such as protocol creation or testing.
3. Draw samples of raw materials, or intermediate and finished products for validation testing.
4. Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
5. Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
6. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for medical, electronics, or other types of production.
7. Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
8. Perform IQ/OQ/PQ activities for equipment/machine/jig and process.
9. Create, populate or maintain databases for tracking validation activities, test results or validated systems.
10. Identify deviations from established product or process standards and provide recommendations for resolving deviations.
11. Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
12. Resolve testing problems by modifying testing methods or revising test objectives and standards.
13. Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
14. Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
15. Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
16. Perform task as assigned by superior.
17. Continuous support for ISO 13485.