I.      Position Summary

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.

II.      Job Responsibilities (starting from verbs, with % of time spent on specific tasks)

Assessment Project handling (weight 80%)

1. Perform product assessment according to standard requirements, regulatory requirements, internal requirements, code of conduct.
2. Review technical documentation of the manufacturers and give the suggestion of certification decision.
3. Develop the technical capacity of the authorized product scope
4. Handle customer complaint or inquiry from competent authorities
5. Support sales and marketing activities in technical field

Operating support (weight 20%)

6. Support the daily operation of auditing section
7. Perform other duties assigned by Department Manager

III.      Job Requirements (knowledge, experience, skills, abilities, etc.)

1. Bachelor’s degree or above in Biomedical Engineering, Electronic Engineering, Automatic Control or the similar majors. Master degree is preferred.
2. Minimum 5 years working experience in the fields of medical device design / production / product quality control or similar working experience.
3. Good command of English.
4. Working experience in quality system management is preferred.
5. Good communication and interpersonal skills
6. Diligence; strong teamwork spirit; self-motivation, and self-improvement
7. Can work independently and efficiently and work under pressure