1. Follow corporate Product Commercialization Process requirements.
2. Prepare and track product test schedule, resources preparation and allocation, and risk management.
3. Develop product test plan, test procedures and periodic product quality report, update Requirements Traceability Metrics.
4. Participate in medical system function, performance, regulatory and reliability testing, or other testing (Such as automation, embedded software, system integration testing) that project needs. Track and report product quality status to core team.
5. Act as an effective team member, provides independent review on deliverables, Such as requirements and technical documentation.
6. Work with design team, develop test jigs which required by project testing.
7. Verify design changes, attend CCB meeting as quality representative.
8. Working on product compliance issues, coordinate the defects review meeting.
9. Test support for 3rd party agency testing.
10. Provide engineering support to transfer products to manufactory.
11. Coach team member to improve individual’s competency.
12. Supervise Quality Engineer in engineering sample receiving activities, analyze incoming quality data. Follow Nonconforming Product processes to facilitate Material Review Board in managing nonconforming product and related quality activities.
13. Depending on the business needs of company, the supervisor of this position can give extra temporary or regular assignment, which is not included.
14. The staff in this position should know the quality management system of the company.
15. The staff in this position should work safety and follow security policies and security procedures formulated by the company.
16. The staff in this position should know and follow the business conduct of company.
1. B.S. Degree in mechanical, electronic engineering.
2. At least 5 years working experience, 2 years medical product function, performance, regulatory, reliability or other testing is must.
3. Good team work and willing to share knowledges with team memebers.
4. Experience monitoring product performance and identify opportunities for improving quality in advance.
5. Demonstrated experience in supporting R&D organization is desired.
6. Capable of managing programs, products and people.
7. Good communication, presentation skill and team oriented.
8. Good command of both Chinese and English (Oral and written).