Mgr, Quality Intelligence

Essential Job Functions:

1. Lead the Product Technical Requirement management that includes but not limited to:

• Work effectively with in-Country RA and Corporate RA and cross-functional groups to review and approve the technical product requirements before submission to ensure the requirements are incorporate into EW's QMS to guarantee higher-quality products.
• Collaborate with BUs, country RA and manufacturing sites to develop the risk mitigation strategies to comply with the requirements of product technical requirement.
• Support product technical requirements related projects and drive the process of the projects from China quality perspective.

2. Continousily improving the process and Coordinate with Edward's global standards management council to conduct standards impact assessments on Edwards' product design, manufacturing process and regulatory strategies from China quality perspective.

3. Participate in assessments and analysis of regulations and standards changes and work with Edwards' global RI team and subject matter experts to support the decision-making process to understand and priorities the regulatory risk & opportunities in China; Support to develop the strategies and identify appropriate actions to comply with the requirements.

4. Support process owner to establish and maintain quality management process of pre-market, such as registration review, self-inspection, IFU &Label etc, and provide governance from quality perspective.

5. Support delivery trainings of quality related regulations, guidance, and standards to global stakeholders; Assist in the collection and maintenance of regulatory intelligence outputs: newsletter, etc. and distribution to organization; Maintain and support the quality-related regulatory intelligence databases and monitor compliance with regulations for follow-up actions.

Education/Experience:

1. Bachelor's Degree or above in related field

2. At least of 5 years experience in active medical device quality management and/or product design and development, 7+ years in medical device experience.

Required Skills:

• Candidates with in-depth knowledge of active medical device standards are preferred, such as GB 9706 series standards.
• Demonstrates profound knowledge and expertise in active medical device product design or quality management.
• Demonstrated problem-solving , critical thinking, and investigative skills ability to build stable working internal/external relationships
• Ability to manage competing priorities in a fast paced environment
• Professional level proficiency with MS Office Suite (Outlook, Word, Excel, Power Point)
• Highly organized and able to work independently to meet deliverables on time and on target
• Strict attention to detail
• Able to multitask effectively and work independently
• Good knowledge of medical terms and human anatomy
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Strong written and oral communication skills in English and Chinese
• Willingness to travel and support regional / local team