This position is responsible for performing product and technical documentation assessment in the field of Active Medical Product (AMP) and delivery the assessment result to support the certification decision.
Assessment Project handling (weight 8 0%)
- Perform product assessment according to standard requirements, regulatory requirements, internal requirements, code of conduct.
- Review technical documentation of the manufacturers and give the suggestion of certification decision.
- Develop the technical capacity of the authorized product scope
- Handle customer complaint or inquiry from competent authorities
- Support sales and marketing activities in technical field
Operating support (weight 2 0%)
- Support the daily operation of auditing section
Perform other duties assigned by Department Manager
- Bachelor’s degree or above in Biomedical Engineering, Electronic Engineering, Automatic Control or the similar majors. Master degree is preferred.
- Minimum 5 years working experience in the fields of medical device design / production / product quality control or similar working experience.
- Working experience in quality system management is preferred.
- Good communication and interpersonal skills
- Diligence; strong teamwork spirit; self-motivation, and self-improvement
- Can work independently and efficiently and work under pressure
