岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

Ensure implementation and overall compliance of the Quality Management System (QMS)，processes and products to any mandatory or elective regulatory/quality requirement set by the organization.

确保质量管理体系(QMS)和流程以及产品的实施全面符合公司制定的任何必须的/选择适用的法规及质量要求。

主要职责 / Main Accountabilities

质量保证/Quality Assurance

建立和发展质量保证团队，确保所有QA相关流程的良好实施，包括产品发布，CAPA，变更控制，NCMR，开发，Rework等。

Establish and Develop quality assurance team to ensure all QA related processes are well implemented, including product release, CAPA, Change Control, NCMR, Dev, Rework and etc.

定期向上级报告关键质量问题

Periodically report provided to superior for key quality issues

担任转移项目的质量代表来支持团队实施项目转移

Acting as quality representative for transfer project to support team for transfer implementation.

根据内部客户反馈或其他BMX站点的基准，继续改进QA相关流程。

Continue improve QA related process based on internal customer feedback or benchmark with other BMX sites.

负责苏州工厂生产产品的工厂放行

Responsible for product release in BSuB site

验证/Validation

制定并执行项目资质计划，包括但不限于设备、设施、公用设施、工艺及方法等。

Establish and execute project qualification plan including but not limited to equipment ,facility, utility, process, method and so on.

协调和监管内外部验证活动。

Coordinate and Supervise the internal and external validation activities.

质量控制/Quality Control

负责质量控制程序的制定和实施，包括来料检验、半成品检验、成品检验、稳定性检验、OOS调查等。

Responsible for activities engaged in quality control procedure establishment, implementation including in-coming testing, semi-finished testing, finished goods testing, stability testing, OOS investigation and so on.

负责环境监测;

Responsible for environment monitoring,

负责校准程序

Responsible for Calibration program

负责抽样计划的制定和实施

Responsible for sampling plan establishment and implementation

支持产品性能研究和相关测试。

Support product performance study and related testing.

在QC实验室实施良好的实验室规范

Implement good laboratory practices in QC lab

质量体系管理/QMS

负责质量体系的建立和提高

Responsible for QMS establishment and improvement

负责文件控制和记录管理

Responsible for document control and record management

负责内审执行和外审协调来保证系统符合合适的法规及标准

Responsible for internal audit implementation and external audit coordinate to ensure the system is consistently complying to applicable standards and regulations

负责供应商相关的质量管理，包括新供应商确认，供应商质量问题处理等等

Responsible for Supplier related quality management including new supplier qualification, supplier quality issue handling and so on

其他Others

密切监控法规的演变，实施差距分析，并跟进缓解计划的实施

Closely monitor regulation evolvement, implement gap analysis and follow up on mitigation plan implementation

负责QA/QC团队的管理

Responsible for QA/QC team management

知识、语言和经验要求 / Knowledge, Language And Experience

本科及以上学历，生物医学工程相关专业或工作经验

Bachelor degree (equivalent) or above educational background, majoring in Biomedical Engineering or related working experience .

语言技能：英语和中文听、说、读、写熟练

Language skills: Proficient in Listening , Speaking, Reading and Writing of both English & Chinese.

6年以上医疗器械生产或医药行业质量管理经验及至少3年团队管理经验

6+ year above similar QA/QC/QMS activities in Medical Device；> 3 years team management experience

熟悉ISO9001 & 13485 & GMP， 熟悉医疗器械及体外诊断试剂相关法规经验

Familiar with ISO9001& 13485 & GMP and Medical Device or IVD related regulations

有良好的团队合作能力

Good Interpersonal skill and team player.