CAPA专员

JOB DESCRIPTION:

主要职责/Key Responsibilities：

1. 与各级管理层和关键利益相关方进行自信有效的沟通, 能及时上报需要升级的质量问题。Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.

2. 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.

3. 运用各种方法（如六西格玛根本原因分析/问题解决技能）与跨职能团队合作。Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).

4. 能独立调查，收集数据，并进行初步分析。Independently investigate, gathers data, and perform preliminary analysis

5. 处理请求，确保责任人被分配，并根据质量目标及时提供反馈和批准。Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.

6. 主导CAPA相关的会议和沟通，包括更新、信息共享及问题反馈。Lead meetings and communications for CAPA updates, information, and concerns.

7. 负责协助按既定流程定期进行指标统计和报告。Responsible for assisting with metrics and reporting on a regular basis in accordance with established procedures.

8. 支持团队开展并监督CAPA培训项目的实施。 Support team in the delivery and oversight of CAPA training program.

9. 协助在电子系统中启动、处理并完成CAPA记录。 Assist in the initiation, processing and completion of CAPA records in the electronic system.

10. 作为CAPA SME, 在审核和检查期间提供支持和专业知识。 As CAPA SME, provide support and subject matter expertise during audits and inspections.

11. 主导或参与持续改进项目和相关活动。。 Lead and/or contribute to continues improvement initiatives and projects.

12. 上级安排的其他工作。 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2年CAPA或医疗器械质量保证相关工作经验。At least 2 years of previous CAPA and/or 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

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