- Location
- China > Shanghai : No. 151 Libing Road, Zhangjiang Hi-Technology Park
- Type
- Full-time
- Source
- Workday
Description
JOB DESCRIPTION:
职位目标 Job Purpose:
在公司内建立并管理质量政策，确保产品质量符合出口国（美国、欧洲、韩国、日本等）及中国的法律、法规及客户要求；制定、维护和更新公司质量手册、质量管理程序文件及各级标准操作规程；监控采购、生产、检测、贮存、货运等各个与质量相关的环节；协调并开展各项质量活动；维护及完善公司质量管理体系。
Set up and manage the Quality Policy and Quality Management System of the company to ensure the product quality meets the code of the export country (U.S.A, Europe, Korea, Japan etc.) as well as China and meets all customers’ requirements. Drafts, maintains and updates Quality Manuals & SOPs. Manages all quality relevant activities ranging from purchasing, production, testing, storage and delivery. Arranges and implements the quality assurance activities. Maintains and improves the Quality Management System to ensure product performance, safety and regulatory compliance.
负责按照监管机构及法规要求完成中国市场产品注册并为SPD提供注册支持活动。
Responsible for company regulatory affairs, primarily for the Chinese market clearance as well as support activities for SPD market clearance.
主要工作职责 Key Responsibilities:
- 掌握中国、美国、欧洲、韩国、日本等国家相关法律法规的动态，相应修订公司的相关要求使之符合上述法律法规的规定。Monitor the trends of relevant laws and regulations in such countries such as China, U.S.A, Europe, Korea, Japan etc. Edits the company’s relevant requirements to meet the regulation as above mentioned.
- 负责制定、维护和更新公司质量手册及公司标准操作规程文件，协同技术部门制定并审核产品工艺、标准操作规程及各类技术质量管理制度，并督促各部门组织实施。Responsible for drafting, maintaining and updating Company Quality Manuals & SOPs, Coordinating with TS-R&D and Ops Depts. to draft and audit production process, SOPs and quality system and overseeing implementations in production.
- 负责审核文件变更请求，标签变更请求，偏差记录，不合格材料/产品的处理，在适当的时候签发预防/纠正措施，并负责对上述文件进行追踪和评估。 Responsible for reviewing Document/Label Change Requests, Deviations, Non-conforming issues, issuing Corrective and Preventive Actions (CAPA) when needed and following up their implementations.
- 严格监控和质量相关的各个活动，包括采购、生产、检测、贮存、货运等各个环节，并协助各部门做好生产现场管理工作，使得产品生产的全过程都在严密的质量监控下进行。在发生产品质量事故的时候，及时深入现场，做好事故分析处理工作，分析原因、确定整改措施并督促相关责任部门落实整改。 Responsible for supervising all quality relevant activities ranging from purchasing, production, testing, storage and delivery and coordinating the production site management to ensure the process is under stringent quality system. When quality issue occurs, inspect production site, find out the root cause, identify corrective & preventive actions and verify the effectiveness.
- 定期组织召开质量会议，分析产品质量现状、客户投诉、供应商绩效等，跟踪落实相关任务。Responsible for organizing routine quality meetings to analyze the current situation of product quality, customer complaints, supplier performance and follow up the actions to be taken.
- 对产品放行工作负责。 Responsible for product release activities.
- 组织公司参加并通过GMP、ISO、FDA认证及客户审计。组织公司内部审计及供应商审计。Responsible for external audit from GMP, ISO, FDA and customers. as well as internal audit and supplier audit.
- 组织召开公司质量管理评审会议。Responsible for arranging the Management Review for Quality System.
- 制定本部门员工的培训计划。Responsible for framing the training schedule for department staff.
- 负责公司全员质量体系相关培训。Responsible for the quality system training for all staff.
- 承担预防性改进公司产品质量体系及提高员工GMP意识的责任。Responsible for preventive initiations of quality system and GMP awareness improvement.
- 按任命书要求担任公司管理者代表。Take responsibility of management representative per appointment from top management.
- 负责按照监管机构及法规要求完成中国市场产品注册并为SPD提供注册支持活动。Responsible for company regulatory affairs including Chinese market clearance, as well as support activities for SPD /market clearance.
- 完成公司安排的其他合法任务。Other QA/RA tasks as assigned by the company.
任职条件Qualifications
文化程度Education:
Bachelor’s degree or above, chemical engineering, biotechnology, medicine or engineering related majors.
任职经验Working Experience:
具备10年以上医疗器械质量系统/技术管理经验。
More than 10 years of managerial experience in Quality System/Technical Management of medical device industry.
专业知识/技能Professional Knowledge/Skill:
- 熟悉医疗器械的生产工艺，熟悉整个过程监控和管理，能编制相关质量管理体系文件及生产工艺文件。 Familiar with the production process of medical device and managing the whole process. Writing quality system documentation and production process procedure.
- 熟悉GMP、ISO、FDA等质量管理体系要求，了解相关法律法规。Familiar with quality system requirements of GMP, ISO & FDA and related regulatory.
- 具有ISO13485质量体系内审员资格。Internal Auditor Certificate of ISO13485 or equivalent.
计算机及外语水平Computer & Language Skill:
- 良好的英语沟通和书写能力。 Good English skills both spoken and written.
- 电脑操作熟练，包括Office软件。Fluent in using PC including Office Software.
能力要求Competency:
- 具有较强的人际沟通/协调能力，能妥善处理客户的建议和投诉。 Strong communication/coordinating skills to handle customer complaints and inquiries properly.
- 具有较强的组织能力，能组织公司各部门定期召开质量分析会和质量管理评审会。Strong organizational skills to arrange quality meeting and quality management review.
- 团队合作精神。Good teamwork skills.
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:
CSP ARDx Consumer Services and Products
LOCATION:
China > Shanghai : No. 151 Libing Road, Zhangjiang Hi-Technology Park
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
