職責描述：
1. Support new product development and other QMS activities as needed.
2. Provide support to engineering staff, to ensure relevant clauses from safety standards are translated into design input requirements.
3. Support CFDA and FDA product registrations.
4. Project manage the third-party certification activities for New-RT development projects to ensure successful outcomes.
5. Advise risk management team on how to document risk items as required by IEC 60601.
6. Review engineering change requests to determine impact on compliance certification.
7. Support the implementation of the New-RT Quality Management System.
8. Deliver against the company performance metrics for IEC compliance and related activities.
9. Conduct internal audits as assigned.
10. Foster a strong‘right first time’compliance culture.
11. Perform other tasks as assigned.
12. Some travel expected
Specific tasks include:
1. Support QMS roll out to the Wuxi facility and provide RA/QA support to other sites as needed.
2. Analyze all applicable safety standards and CFDA/FDA guidance documents, to ensure applicable clauses are considered in the design.
3. Develop and Maintain a detailed plan for all IEC related compliance activities.
4. Be an‘internal consultant’ to the development team through new product development., including providing training as well as support for risk management, usability and V&V processes.
5. Manage relationship with Beijing Institute of Medical Device Testing (BIMT), including:
Set up working group with BIMT to organize information exchange as part of product registration
Generate test plan for registration testing and get agreement from BIMT on test plan acceptability for product registration (IEC 60601-2-64/IEC 62667)
6. Manage registration testing during installation and commissioning to complete testing and resolve issues in a timely manner.
7. Maintain list of critical components per IEC 60601-1, notify test house of changes.
8. Support the business to ensure purchased parts conform to required safety standards
9. Ensure all product labeling satisfies regulatory requirements.
10. Maintain up to date compliance work and certification for each New-RT product.
11. Provide support for CAPA, internal audit and management review as needed?.
12. Report on status of compliance activities at the project meetings and to management.

任職要求：
1. Bachelors Degree (or equivalent experience) and 5-10 years of related experience.
2. Preferred Skills.
3. Engineering .
4. Medical device or regulated industry experience.
5. Experience of IEC 60601-1 Safety Series.
6. Lead Auditor ISO 13485 is as advantage.
7. Excellent English with strong interpersonal skills.

新瑞陽光粒子醫療裝備（無錫）有限公司是總部位于美國加州硅谷的NewRT Medical Systems, Inc.在中國的全資子公司。公司由一批來自全球頂尖放療設備廠商Varian, IBA, 美國著名大學和國家實驗室的高級專家和高級技術管理人員創建，并獲得美元基金的巨額投資和無錫當地政府的大力支持，專注于新一代影像引導放療裝置的開發、生產和銷售，立志打造世界水平的國產化先進放療裝置。

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