质量体系专员

JOB DESCRIPTION:

主要职责/Key Responsibilities：

1. 管理公司适用过程的文件体系和要求。确保所有 QA 文件都符合事业部、集团和监管规定的要求，并且为当前最新版本。Manage the documentation system and requirements for assigned operations.Ensure all QA documents meet established divisional, corporate and regulatory requirements, and are current and up to date.

2. 识别文件体系中的任何差距，并采取必要的措施来纠正和改进。Identifies any gaps in the documentation system and take necessary actions tocorrect and improve. Develop and improve on the documentation routing process to assure timely implementation of requested changes.

3. 支持内/外部审核的审核准备工作，包括培训员工/指导审核的准备工作。Support Audit Readiness activities for internal/external audits including training staff / guidance in preparation of the audits.

4. 负责内/外部审核改进的跟踪和关闭。Responsible for tracking and closure of internal and external audit improvements

5. 根据既定程序，负责协助定期进行各类指标统计和报告。Responsible for assisting with metrics and reporting on regular basis in accordance with established procedures.

6. 参与或主导CAPA项目的完成，协助启动、处理和完成电子系统中的CAPA记录，确保记录的合规性和及时性。Participate in, or lead, the completion of CAPA projects, assist in the initiation, processing and completion of CAPA records in the electronic system, assuring compliance and timeliness of records.

7. 跟踪、报告不合格情况并进行趋势分析，减少不合格 Track, trend, report and reduce nonconforming situations.

8. 支持异常报告的解决和批准，并管理不合格的已确定的纠正预防措施计划。 Support the resolution and approvals of exception reports and manage the identified corrective and preventive action plans for the nonconformities.

9. 支持仪器运营相关质量培训。 Support the quality training related to the instrument operations.

10. 主导和/或参与持续改进计划和项目。 Lead and/or contribute to continues improvement initiatives and projects.

11. 领导安排的其他工作。 Perform other duties as assigned by Management.

任职资格/Job Requirements：

1. 资格证书/Certificate：

质量管理体系内审员证书
Quality management system internal auditor

1. 外语技能/Foreign Language Skills：

英语听、说、读、写流利
Fluent in listening, speaking, reading and writing English

1. 计算机软件技能Software Skills：

熟练掌握WORD, EXCEL, POWERPOINT等办公软件
Proficient in WORD, EXCEL, POWERPOINT and other office software

1. 工作经验或专业背景/Work Experience or Professional Background：

至少3年医疗器械质量保证相关工作经验。
At least 3 years of quality assurance/experience in Medical Device.

1. 教育背景/Education Background：

学士及以上，机械、电子、工程、化学、药学、生物学或微生物学或同等经验
Bachelor’s degree or above, Mechanical, Electronic, Engineering, Chemistry, Pharmacy, Biology or Microbiology or equivalent experience

1. 其它要求/Others：

熟悉ISO13485标准、中国体外诊断试剂/医疗器械相关标准/法规
Familiar with ISO13485 standard, Chinese in vitro diagnostic reagent/medical device related standards/regulations
具有数据统计分析，六西格玛根本原因分析/问题解决培训和经验优先
Data analysis, Six Sigma root cause analysis/problem solving training and experience preferred.

The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION: ##LOCATION:
China > Hangzhou : #198 12th Street, Hangzhou Economic & Technological Development Area

ADDITIONAL LOCATIONS: ##WORK SHIFT:
Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable