国内净水器价格联盟

苏州招聘 |碧迪医疗器械公司5大岗位招聘(年薪300000+)

楼主:苏州招聘通 时间:2018-12-09 11:24:23

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企业介绍

BD是一家全球化的医疗技术公司,通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD在保护患者和医护人员安全、强化医学研究和临床实验室建设领域居于世界领先行列。公司提供创新的解决方案,以帮助推进细胞学和基因组学研究、加强传染性疾病和癌症的诊断、改善药物管理、促进感染预防、为手术及介入治疗提供工具、优化呼吸治疗,并支持糖尿病管理。BD与全球范围内的机构组织携手,共同应对最具挑战的全球健康问题。公司在逾50个国家拥有分支机构,员工超过45,000人,公司与客户及合作伙伴紧密协作,以帮助改善医疗结果,降低医疗护理成本,提升效率,保护患者和医护人员安全并增加医疗可及性。


岗位信息

1、检验员 2人

职位描述:
Job Description
Job Title 职位: QC Inspector 检验员(过程/来料、出货)
Department 部门: QA 质量部
Job Location 工作地点: BD Medical, Suzhou Plant 碧迪苏州工厂
Job Grade 职级: JG 2
Report to 汇报人职位: Sr. QA Engineer资深质量工程师
Subordinates 下属: None 无
POSITION SUMMARY(职位概述)
负责进货/过程/成品检验
KEY RESPONSIBILITIES(主要职责)
1.负责原辅材料、过程检验、成品检验、产品周期检验及相关验证等的检验工作,确保数据准确,及时出报告;
2.负责检验报告的填写、分发及检验记录的整理和保存;
3.对于检验过程中发现的产品质量不合格情况通知上级主管,并视情况签发不合格品报告或纠正预防措施;
4.负责产品检验状态标识和成品留样的管理;
5.做好检验区域5S;
6.完成交付的其他相关工作。
SKILLS AND ABILITIES(技能)
1.具有高中或以上学历;
2.至少3年以上外资企业从事质量检验工作经验;
3.能熟练使用常规的计量工具,有拉力仪及显微镜检验经验的优先;
4.具有数据统计知识;
5.具有良好的观测能力;
6.能熟练使用计算机及办公软件;
7.具有良好的沟通交流能力;
8.了解ISO9001和ISO13485质量管理体系知识。


2、助理注册事务经理 1人   30-40万/年

职位描述:

POSITION SUMMARY

Reporting to the Medical Device Regulatory Manager BD China, works with a team of regulatory affairs professionals to ensure establishes best practices within the assigned area of responsibility. E.g. CFDA Pre-market approval submission & regulatory reporting, design controls for new product development, technical standards, collection and dissemination of intelligence, influencing the global regulatory environment, etc.

KEY RESPONSIBILITIES

1. Prepare pre-market submissions (including type testing, registration files etc.) and obtain approval of premarket product registration timely.

2. Acts as the Regulatory partner for the BU he/she is responsible for.…

3. Interact with CFDA on registration requirements and monitor changes to requirements.

4. Independently manages and provide regulatory guidance to multiple long-term projects without direct supervision.

5. Manages a single discipline within the unit on a project or short-term basis.

6. Interacts with manager as required by specific issues, milestones, or status changes.

7. Represents BD externally in long term project in specific fields.

8. Accepts accountability for RA within BD on multi disciplinary platforms.

9. Manages the regulatory review of labels, labeling, promotional materials, clinical protocols, and clinical reports for products that are under his/her responsibilities.

10. Ensures compliance with China regulatory requirements, including but not limited to change management, Chinese labeling requirements, etc.

11. Monitors regulatory and Standards developments affecting BD product he/she is responsible for, Identifies and recommends committees that BD should be part of.

SKILLS AND ABILITIES

1. Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.

2. Ability to communicate (oral/written) and interact effectively across all levels, disciplines, and regions, particularly with regulators and Standard committee members. Independently authors written reports/documents for distribution within division.

3. Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas. Assesses corrective action to assure it prevents recurrence. Able to confidently deal with ambiguous issues and provide input towards suitable actions.

4. Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions/dossiers.

5. Experienced in meeting with, making presentations to, and negotiating with regulators, including complex or sensitive issues.

6. Demonstrated success in developing strong working relationships with regulators and external groups (e.g., trade associations) in order to influence effectively and bring about consensus on policies that support business objectives.

7. Minimum 3 years of directly related experience in medical device, or pharmaceutical fields, and three or more years of management experience.

8. Interprets subjective and complex aspects of specific regulations and has general understanding of multiple sets of associated regulations.

9. Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes. Recognized internally as technical or subject matter expert in multiple areas.

10. Suggests opportunities for improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing implementation plan.

11. Independently manages and monitors multiple complex and diverse short term and long-term projects without direct supervision. Interacts with manager as required by specific issues, milestones, or status changes. Maintains a “focused urgency” as required by specific events.

12. Asserts own ideas and persuades others. Fosters collaboration among team members. Recognized as leader within department.

13. Formulates short term planning for individual deliverables/contributions and participates in long term planning within the department.

DESIRABLE

B.S. or B.A. degree in a technical discipline (electrical engineering, bioengineering, chemical, biology, pharmaceutical preferred).


3、客户经理 1人   20-30万/年

职位描述:

Job Description

POSITIONSUMMARY(职位概述)

该职位负责与当地的PAS产品经销商合作进行PAS相关产品的销售,其中包括管理,协调,物流支持和区域销售促销活动。

KEYRESPONSIBILITIES(主要职责)

负责所属区域的相关产品的销售及推广,完成销售任务;协调地区销售经理/区域销售经理完成本地区的销售任务,并协助当地的销售代表举办推广活动。

在指定的目标医院开展产品销售及技术指导;掌握产品知识,负责医学教育和产品培训;联络、发现、培养本地区KOL。

培养本地区KOL及协助地区销售经理/区域销售经理培养区域的讲者。

积极学习,不断完善销售技巧及产品知识,随时与客户保持紧密联系,了解、把握、努力达到客户需求。

配合地区销售经理/区域销售经理制定区域内代表的培训计划并参与培训带教。

关注、收集所辖区域竞争对手的情况,配合相关经理制定市场对策并实施。

负责处理相关产品的质量投诉。

关注、收集所辖区域竞争对手的情况,配合相关经理制定市场对策并实施。

严格遵守国家合规相关法律和公司合规相关规定、规范。

SKILLS ANDABILITIES(技能)

大专以上学历,临床实验室医药或护理相关专业。

3-5年销售经验。

工作主动,能够独立工作,有一定的抗压能力。

优秀的销售和交际能力,擅于沟通、协作。

有较强的和同事、商业伙伴和客户建立和维持良好的关系的能力。

能够在指定时间框架内处理和完成多项任务。

良好的组织能力,能够平衡有限的人力、财力和物力及时有效地完成既定的业务目标。

DESIRABLE(优先条件)

有相关产品销售经验。

流利的英语口语和良好的文字能力。


4、注射用水技术员 1人

职位描述:

POSTION: WFI SYSTEM TECHNICIAN 注射用水技术员

GENERAL FUNTION

基本职能

Engaged
in all activities relating to the PS Business Unit Water for Injection system including
but not limited to Operation, periodic, preventive and remedial maintenance for
WFI system, supporting the PS’s production activities through WFI system caring
and enhancement, promoting operation safety in the plant.

从事制药系统事业部注射用水系统运行,定期的预防维护和应急维护,但不限于这些。不断改进和提高注射用水系统的安全和性能 ,保障生产顺利进行。

JOB RESPONSIBILITIES

工作职责

Critical Utility System关键公用系统

To
conduct routine surveillance on WFI system and its expected performance.

注射用水系统、日常点检和运行管理

To
produce reports based on monitoring of WFI systems and conduct for periodic and
preventive maintenance, carry out remedial or rectification works where
necessary.

报告注射用水系统运行状态和参数,进行定期维护保养和故障修复工作。

Be
engaged with supervision of outsourcing sub-contractor.

外包商监督和管理

Participate
and implement specific tasks regarding EHS and 5S activities.

根据EHS和5S的要求参与和执行所分派的任务

New Equipment Testing
& Commissioning新设备调试

? To assist the Engineer
in leading and carrying out Testing & Commissioning of all Utility system
and equipment for new equipment installation.

协助工程师对新设备进行调试

? To assist the engineer
in producing and reviewing Testing & Commissioning reports of all
electrical facilities system and equipment for new equipment installation.

协助工程师完成设备试运行报告

Others 其他

? Performs any other
task(s) as assigned, or defined in related quality procedure.

其他指定的工作或在质量文件中定义的职责。

(All required authority will be issued to implement
responsibility listed above automatically after the approval of this Job
Description).

(本职位描述批准后,所有相应的权限将自动生效以履行上述职责。)

JOB REQUIREMENTS

职位要求

Education 教育

? Diploma
or Vocational Certificate or Degree.

大专或技校毕业

Experience 经验

Minimum
3 years’ experience in critical utilities system in the following environment:
Pharmaceutical or medical device Manufacturing Plant

至少3年药厂或医疗器械生产企业关键公用工程工作经验

Familiar
with EP/USP/CFDA requirement on water and its generation system

熟悉各国药典关于水质和水系统的要求

Familiar
with normal water treatment process incl. but not limited to: MMF/ Softener/
ACF/RO/EDI/Distiller

熟悉常用水处理工艺包括但不限于:多介质过滤/软化/活性炭过滤/反渗透/电除盐/蒸发器

Familiar with normal process like:

Familiarity
with GMP or ISO13485

熟悉GMP或ISO13485

Skill / Knowledge / Abilities 技能/知识/能力

Strong
technical knowledge, abilities and competency in Mechanical Machinery/ Electrical
System and equipment

较强的机械设备技术知识和能力

Strong
hands-on skills in maintaining and trouble-shooting Electrical System and
equipment.

较强的电气设备维护和故障处理动手能力

General
Automation and Control knowledge is preferred

具备常用自动化和控制知识尤佳

Strong
problems analytical and solving skills.

较强的问题分析和解决能力

Work
well under pressures with short deadlines and least supervision.

能够自觉地按期完成各项工作

Ability
to work under odd hours and be present under emergency calls.

能够在非正常工作时间随时到工厂工作

Willing
to work on shifts when necessary.

如工厂需要,愿意轮班

Good
inter-personal skills and ability to work cohesively within a multinational
team in an international environment.

良好的沟通技巧,有在跨国公司工作背景

Ability
to learn quickly and adjust personally to changes in customer requirements.

能够快速学习和自我调节来适应工作需要

Loyalty
and good ethical behavior.

诚实守信,良好的个人操行

Knowledge
in Chinese Language and Technical Terms. Knowledge in English is preferred.

基本的汉语和专业术语交流能力,有英语沟通能力尤佳

Interaction交叉关系

Internal
customer (Manufacturing, Material and Quality etc...)

内部客户(生产、物料和质量部等)


5、生产领班 1人

职位描述:
POSITION职位: MANUFACTURING LINE LEADER生产领班
Dept./Unit部门 : Manufacturing Dept生产部 Location工作地: Suzhou苏州
Job Grade职级: □JG1 ■JG2 □JG3 □JG4 □JG5 JD Version版本: 3
GENERAL FUNTION
基本职能
?Lead the group to complete the daily manufacturing operations with good quality by following the process procedures.
带领小组按照工艺规程优质完成日常生产操作。
JOB RESPONSIBILITIES
工作职责
?Follow the process procedures in the daily operations
在日常操作中遵守工艺规程的要求。
?Implement and complete the production plan timely.
按时执行并完成生产计划。
?Run the manufacturing equipment per the process requirement.
根据工艺要求运行生产设备。
?Basic problem solving for the equipment.
设备的基本问题解决能力。
?In-process quality control.
在线质量控制。
?Train the manufacturing staff.
对生产人员进行培训。
?Follow the company’s EHS policies.
遵守公司的EHS政策。
?Need work in shifts
需要轮班工作
Leadership Roles领导作用
?Responsibility of the incumbent to perform all tasks in a safe manner, keeping in mind safety awareness at all time.
安全的执行各项工作,并时刻保有安全意识。
?Responsibility for directing line operators and management to drive breakthrough.
指导操作人员并通过管理力求突破。
Others其它
?Performs any other task(s) as assigned, or defined in related quality procedure.
完成其它安排的任务,或相关质量程序中定义的工作。
(All required authority will be issued to implement responsibility listed above automatically after the approval of this Job Description).
(本职位描述批准后,所有相应的权限将自动生效以履行上述职责。)
JOB REQUIREMENTS
职位要求
Education教育水平
?Professional school or high school above
中专或高中以上学历
Experience工作经验
?3 years above experience in multinational company is preferred
三年以上跨国公司工作经验优先
Skill技能 / Knowledge知识 / Abilities能力
?Good hands-on operation skill.
良好的动手操作技能
?Good learning ability.
良好的学习能力
?Good communication skill.
良好的沟通能力
?Some English skill in reading and writing is preferred.
英语读写能力优先
?Computer skill is preferred.
电脑技能优先
?High level of loyalty and integrity.
较高的忠诚度和正直性
?Good analytical and problem solving skill.
良好的分析和问题解决能力
?Good ethical behavior, ensuring that activities carried out all parties representing the Manufacturing Department within and outside the organization are executed in accordance with the Company’s Code of Ethics, with professionalism and in the best interest of the Company.
良好的道德表现,确保在组织内部和外部代表生产部所进行的活动遵循公司的道德准则,具备专业精神并维护公司的利益。
Interaction交叉关系
?Internal customer (Reagent Manufacturing Team, etc.)
[drivers:- production scheduling, in-process and finished product quality, etc.]
内部客户(试剂生产团队等)
[ 驱动:生产计划、过程产品和成品质量等]
?Inter-department (Engineering, Quality, Product Support, Materials etc.)
[drivers:- validation implementation, planning, materials availability, product quality, etc.]
交叉部门(工程部、质量部、产品支持部、物料部等)
[ 驱动:验证执行、计划、物料可用性、产品质量等]
Supervision and Reporting Relationship管理和汇报关系
?Reports to the Section Manager, Assembly Manufacturing.
汇报给区域经理,装配生产。
Working Conditions工作环境 / Conditions环境 / Physical Requirements环境要求
?Manufacturing shop floor environment.
生产车间


福利待遇

做五休二 周末双休 带薪年假 五险一金 包吃 全勤奖 绩效奖金专业培训 交通补贴 加班补贴


联系方式

中国总部
BD上海
碧迪医疗器械(上海)有限公司
上海市南京西路1168号
中信泰富广场30楼
200041, 上海, 中国
Tel: 021-32104610
Fax: 021-52925191
E-mail: ChinaCytometry@bd.com 
 
中国分支机构
BD北京办事处
北京市朝阳区建国路77号
华贸中心3号写字楼28层02B, 03, 05
100025, 北京, 中国
Tel: 010-58139000
Fax: 010-58139191
 
 
中国分支机构
BD广州办事处
广州市东风中路410号
时代地产中心1208室
510030,广州,中国
Tel: 020-83486363
Fax: 020-83486377


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