EY RESPONSIBILITIES（主要职责）

1. Make sure the new project design process meets the NPI procedure

2. Lead the Human Factor and Risk Management for new projects

3. Work with team to ensure the design output meets the design input, and ensure evaluation/assessment is data-driven by using in-depth statistical analysis for robust design

4. Work with manufactory for the Design Transfer, to ensure the manufacturing processes are stable through IQ, OQ &PQ

5. Supplier audit and management for new projects

6. Establish & maintain the QMS in China Design Center

7. Work with Corp. & each Division to ensure the design process meets the Corp. & each Division’s QMS requirements

8. Ensures compliance with federal and local regulations pertaining to GMP, QSR, ISO, CE and other relevant regulations and policies

9. Provide training on QM system process as needed

10. Provide up-to-date training of applicable regulations, guidelines and standards related to Quality assurance

11. Record and monitor non-conformities during product development. Ensure Root-Cause Investigations are completed, and Corrective Actions are implemented in a timely fashion and track the effectiveness

SKILLS AND ABILITIES（技能）

? Minimum Bachelor’s degree in Science or Engineering disciplines

? Minimum of 5 years in medical device industry

? Extensive experience with New Product Design Process

? Hands on experience with quality system management in medical device

? Familiar with the requirements of GMP, and rich experience of Quality System audit by NMPA

? Supplier audit experience

? Solid knowledge in Statistics and hands on experience in using statistic tools

? Ability to handle critical timelines and multiple tasks at the same time

? Creative, analytical problem-solving skills

? Proficient in Microsoft Office Suite and computer-based applications

? Excellent verbal/written communication skills

? Written and Spoken English Proficiency

? Willingness to travel in order to accomplish assignments

DESIRABLE（优先条件）

? Medical device/Pharmacutical company working experience

? Design assurance experience

Working conditions & environment(工作状况和条件):

(如是否需要经常出差? Home based?)

1. Business travel required. 30%

Travel Frequency

0 <25% 25%-50% 50%-75% >75%

上班地址：上海