POSITION SUMMARY（职位概述）
To have the primary responsibility for coordinating the development of embecta Quality Assurance activities. Be responsible for auditing the QA/SMS/RA systems relating to development, support & deployment of medical devices (both software and hardware) for completeness and compliance with FDA and other regulatory requirements. To provide QA/RA support for a national wide wide-area network and for customer support functions.
To Attain and maintain official authority, registration to market and sell the company’s medical devices products under international, FDA and national laws.
To lead the ETO sterilization process cycle development, validation and ETO sterilization service to outside embecta clients.
To lead the ISO implementation in the company.
To establish the proper QC system compliance with the company policy
You will also have the opportunity to develop strategies and multi-year implementation plans for new product introductions and continuous improvement.

首要职责为协调发展embecta质量保障事项。负责审核与发展、支持和部署医疗设备（包括软件和硬件）的完成性，并确保符合FDA及其他相关法律法规的规定。为客服版块提供全国性的QA/RA支持。
参加并维护官方授权、注册事项，保证公司的医疗器械产品能够国际、国家及FDA的批准下售卖。
领导环氧乙烷灭菌工艺的循环发展、验证和服务。
领导ISO在公司的执行。
建立合适的QC系统，以保证符合公司政策。
同样有机会对新项目引进和持续发展项目进行战略规划和长期计划。

KEY RESPONSIBILITIES（主要职责）
1. Identify and implement effective process control systems to support the development, validation, and ongoing manufacturing of products.
判断并执行有效的过程控制系统，以支持生产的发展、验证和持续生产。
2. Act as an effective leader or team member in supporting quality disciplines, decisions and practices.
作为有效的领导人或团队成员，支持质量条例的决策和实践。
3. Review and developing the QA policies and procedures compliance with the cooperate, FDA and other regulatory requirements.
审查并制定符合合作者、FDA和其他相关法律法规的QA政策和流程。
4. Audit compliance with QA policies and procedures. Report audit results to upper management. Work with other managers to create plans for moving toward compliance.
审核QA政策和流程，并向管理层汇报审核记过，与其他经理协作制定计划达到合规要求。
5. Recommend changes to polices, procedures where appropriate based on industry “best practice” and regulatory requirements.
根据“***实践”原则和相关法律法规，就政策、流程提出合适的改善意见。
6. Provide and document staff training on quality-related policies, tools for improving meetings, tools for problem solving with numbers and tools for problem solving with ideas.
根据质量相关政策、改善工具、数字问题解决工具和问题解决思路提供并归档相应的培训。
7. Assist in the development and management of the QA/RA/SMS budgets.
协助制定和管理QA/RA/SMS预算。
8. Supervisory responsibilities include staff development and hiring, firing, and evaluation of staff.
负责制定、雇用、评估下属。
9. Responsible for developing contracts, and monitoring contractors, for outside QA/QC audits.
为QA/QC审核，负责制定合同，监督合同执行。
10. Supervise preparation of marketing authorization applications for new medical devices products.
指导监督新医疗器械产品的营销授权事项。
11. Ensure that document is correct and complete and submitted in due time to the national regulatory agency consistent with the company’s strategic goals for marketing, manufacturing, and selling. Follow up with regular FDA surveillance reports to maintain or renew existing marketing authorizations. Inform national regulatory authorities without delay of reported adverse reactions/side-effects.
确保文件的准确性和完整性，并根据公司的市场、生产和营销战略目标适时地提交国家监管机构。定期维护、更新FDA的监督报告、现有营销授权。无延迟、差错地通报国家监管机构。
12. As the primary company contact with the national regulatory agencies, strength in agency negotiations, formation of strategy for responses to data deficiencies, information and policy monitoring, and acceleration of the review process are required.
做为公司与国家监督机构的主要联络人，必须善于与相关机构谈判、战略性回应数据缺失、信息和政策监控，并且在符合规定的情况下加速审查进程。
13. Developments of the medical devices products supervise preparation, and negotiate with regulatory agencies for approval. Provide input to the International Regulatory Affairs staff on development of regulatory requirements and policies within China.
制定方案，以完成医疗器械产品的监管准备工作，并能与相关机关洽谈批准事项。协助国际RA团队同事在中国境内达成相关法律法规的要求。
14. Keep company management up to date on status of specific product registration actions, problems and solutions. Further, inform management of changing or new national/international legislation and policies of the medical devices, as well as pertinent scientific and political inputs and influences. In this context form strong professional relationships with key-influential political, regulatory and trade association contacts. Attend external seminars, briefings and conferences.
保持公司的管理团队了解最新的产品注册状态、问题及解决方案。另外，通知管理团队医疗器械相关的国内/国际法律法规的变化或者新动态，以及相关的投入和影响。因此必须与有关键影响力的政府机构、监管机构和行业协会联络人保持有密切联络。还需要出席外部研讨会、简报及其他相关会议。
15. Developments of the ETO sterilization process, validation and operation management compliance with cooperate, FDA and local regulatory requirement.
建立符合合作者、FDA和当地监管要求的环氧乙烷灭菌流程、验证及运营管理。
16. Responsible for the sterilized product release according to the cooperate policies and procedures.
根据相关政策法规和流程负责灭菌产品的释放。
17. Performs other duties as may be required by supervisor.
执行其他由主管安排的工作。

SKILLS AND ABILITIES（技能）
1. Bachelor’s degree from a 4-year accredited institution.
本科及以上学历
2. Relevant manufacturing management experience in the medical device field and more than 6 years experience.
6年以上医疗器械相关生产管理经验
3. In-depth knowledge of FDA requirements including management controls, Design Controls, Corrective & Preventative Action, Production and Process Controls.
熟悉FDA条款包括管理控制、设计控制、纠正及预防措施、生产和工艺控制
4. In-depth knowledge of applicable regulatory affairs laws, regulations and policies, both national and international.
熟悉国内及国际的相关申请法律法规及政策
5. Broad knowledge of industry standard “best practices” for Quality Assurance. Demonstrated ability to plan, schedule and coordinate including initiation, development, implementation, and maintenance of large, difficult and complex development projects.
在质量保障方面有广泛的知识可应用于“***实践”的行业标准。有足够的能力规划、安排协调包括启动、开发、实施和维护在内的大且困难而复杂的项目。
6. Commitment to providing excellent customer service.
承诺为客服提供一流的服务
7. Good organizational abilities, oral communications in both Chinese and English and interpersonal skills are needed.
优秀的组织能力，出色的中英文口语交流、交际能力
8. Ability to be a “self-starter” who identifies, resolves, and reports on issues in a timely and effective manner.
积极主动，能及时有效地识别、解决和报告相关问题

Desirable（优先条件）
1. 10Years working experience in medical device field
10年以上医疗器械工作经验