Job Description

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

DESCRIPTION 概述

Quality Personnel should follow the leading of Quality Responsible, specifically instruct and take responsibility of assigned scope and in charge of the company’s quality activities for the compliance of GSP and/or GMP regulation during the business operation. The Quality Personnel also will need responsibility for the duties as required by the supervisor. The Quality Personnel should be familiar with China Medical Device regulation, with the well practice of post market experience could supporting to other departments. possess basic knowledge of European Medical Device Directives, FDA regulation will be preferred.

质量管理人员，应全面遵从质量负责人及管理机构之组织分配，具体指导公司的相关质量活动，对公司医疗器械经营过程中符合GSP和/或GMP法规的要求负责。负责其它上级主管交付的质量相关事务。质量管理人员应熟悉中国医疗器械法规，具有良好的上市后实践经验，可以为其他部门提供支持。具备欧洲医疗器械指令，FDA法规的基本知识者优先。

SUPERVISION RECEIVED 汇报线

Under the direct supervision of the Senior Manager, Quality Assurance

向质量部经理汇报

SUPERVISION EXERCISED 负责范围

N/A 不适用

ESSENTIAL DUTIES AND RESPONSIBILITIES 基本职责

• Gathering local regulations and conducting intelligence analysis.

收集国内法律法规要求及进行差距分析

• Well communication with line Manager for the regulation requirements and receive appropriate resources to establish and improve the QMS to fulfil below regulation required duties. The specific scope and objectives will per the letter of appointment for each team member. When needed, line manager will be making the adjustment of the contents to meet the overall compliance and targets.

与直线经理就法规要求进行良好的沟通，并获得适当的资源来建立/优化质量管理体系，以履行以下法规要求的职责。质量管理人员的具体职责，参见任命书之描述。需要时，质量负责人或质量管理机构可适时调整，以达到整体合规性要求及部门绩效要求。

• Responsible for Service & Repair quality activities

负责维修与服务部相关质量活动。

• Work with global Service & Repair Quality and Manufacturer Quality to draft VMP and related Qualifications, instruct and supervise functions to make sure of compliance.

与总部维修中心及制造商质量同事协调，撰写过程验证及相关确认文件。指导及监督其合规执行。

• Review and approval of service report.

审阅及批准维修工单。

• Support Non-conforming spare parts activities in TrackWise.

支持零配件不合格品的管控及在TrackWise系统中的处置。

• Responsible for Service & Repair Complaint handling, provide Periodic risk assessment

负责维修服务投诉事件的处理，做周期性风险评估分析。

• Leading data collection and for all service and repair activities and reporting QMS metrics for the China S&R center.

领导数据收集所有技服务维修部的活动及汇报QMR。

• Support global quality projects, also including CAPA.

支持总部质量相关项目, 包括CAPA。

• performs other duties as required.

其它上级领导交付的任务。

DESIRED MINIMUM QUALIFICATIONS 推荐基本资质

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

下面列出的要求代表了这个职位所需的知识、技能和/或能力。

EDUCATION 教育背景

Bachelor’s degree or equivalent in scientific major, eg. Medical Device, Mechanical/Electronic, Medicine, Biological Sciences related et al. are acceptable.

本科或同等学历，理工科专业，如：医疗器械、机械/电子、医学、生物科学等相关专业。

TYPE AND NUMBER OF YEARS EXPERIENCE 类型和工作年限

The following requirements are representative of the knowledge, skill and/or ability for this position:

Bachelor’s degree and/or Master degree with 5 years (or above) quality experience in medical device company.

Familiar with GMP and ISO13485 requirement will be preferred.

Knowledge of NMPA regulations and with well post market practice will be preferred.

Knowledge of Oracle, Sale Force are required. Knowledge of EtQ, Minitab will be preferred.

Must possess above average verbal and written skills, organizational and computer skills with good attention to detail. Writes routine reports and correspondence.

Fluent Spoken and written English is required.

以下要求代表了该职位的知识、技能和/或能力：

本科学历和/或以上学历，5年（或以上）医疗器械企业质量工作经验。

熟悉GMP及ISO13485法规要求者优先。

熟悉Oracle, Sale Force. 掌握EtQ, Minitab者优先

了解NMPA法规并具有良好的上市后实践经验者优先。

必须具有中等以上的口头和书面表达能力，组织能力和计算机技能，并注意细节。撰写日常报告和通信。

流利的英语口语及书写。

TOOLS AND EQUIPMENT USED 需掌握的工具及技能

General office equipment, computers, printers, and copiers, fax machines.

一般办公设备，电脑，打印机，复印机，传真机。

PHYSICAL REQUIREMENTS 身体条件

Ability to travel train and/or airplane to domestic or international locations if needed.

如有需要，应能够乘坐火车或飞机到国内或国外出差。

ADVERSE WORKING CONDITIONS 工作条件

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general office environment.

本节中列出的不利工作条件包括但不限于员工在履行本职位的基本职责和责任时可能接触到的环境条件，即一般的办公环境。

SELECTION GUIDELINES 优选指南

Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.

正式申请，学历和工作经历等级；口头面试和背景调查；可能需要进行与工作相关的测试。

DISCLAIMER 声明

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

上面列出的职责仅作为可能执行的各种工作类型的说明。如果工作与该职位相似，相关或有逻辑分配，则遗漏具体职责并不会将其排除在该职位之外。职位描述不构成雇主与雇员之间的雇佣协议，可以根据雇主的需要和工作变化的要求进行修订。

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.