Quality Engineer
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Experience and Knowledge:
- Minimum 2-4 years in quality of Quality System management and exposed to ISO, PMDA, FDA and other regulatory agency inspections
- Experience in manufacturing processes is preferred
- Regulatory Affairs with Quality System Background will be added advantage
- Change management and GMPs experience will be added advantage
- Effective oral and written communication skills
- Effective interpersonal skills
- Ability to comprehend basic principles of engineering, physiology and medical device use
- Ability to solve problems of moderate scope and complexity
- Submissions related word processing skills
- Experience with medical devices
- Fluent in both Mandarin and English language – to handle the China market
Qualifications:
- Bachelor Degree in Science or Engineering or relevant experience
