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2018年11月14日刷新

Medical Device Assessor / 医疗器械审核员

15-25千/月

2018年11月14日刷新

  • 本科

  • 不限

  • 上海

  • 若干

  • 全职

展开职位详情

职位描述

五险一金 员工福利 8小时工作制

职位类别:医疗器械市场推广/销售

Key responsibilities &accountabilities

• Undertake management system assessments in accordance with BSI requirements.

• Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.

• Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.

• Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team

• Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio.

• Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.

• Plan/schedule workloads to make best use of own time and maximize revenue-earning activity.

• Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.

• Maintain and develop assessment skills and technical and management system standards knowledge. 

• Provide technical support to clients through business development, sales and customer service staff

• Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.



Candidate specifications



• Bachelor degree or above with medical related major or an equivalent professional qualification in a relevant subject and have a comprehensive knowledge of business processes and systems, *

• A medical device professional with training and a working knowledge of *

o ISO  & Medical Device CE Marking

o Medical Devices Risk Management – ISO 

o GHTF Basis Knowledge, Process validation, PMS & Vigilance 

• Minimum 3 years working experiences in the fields of medical device or in an area related to materials, manufacturing processes or design*

• Commercial understanding of compliance industry, minimum 2 years quality system management

• Knowledge of business processes and application of quality management standards

• Good verbal and written communication skills and an eye for detail

• Be self motivated, flexible, and have excellent time management/planning skills

• Can work under pressure

• Willing to travel on business intensively

• An enthusiastic and committed team player

• Good public speaking and business development skill will be considered advantageous

• Sufficiently fluent English skills both oral and written to allow: 

 a. Conduct of assessment visits in English plus understanding of related documentation.

 b. Receipt and understanding of all relevant training provided in English 

 C. Effective verbal and written communication in English with clients, regulators and BSI colleagues

  • 年龄要求: 不限
  • 语言要求:不限

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企业简介

英标管理体系认证(北京)有限公司

  • 行业: 检测/认证
  • 规模:
  • 性质: 其他
  • 当前职位: Medical Device Assessor / 医疗器械审核员
  BSI 英国标准协会 成立于1901年,并于1929 年获得英国皇家特许,成为世界上第一个国家标准机构,同时也是国际标准化组织 ISO 的创始成员之一。
      作为世界最早和最具权威的标准制定、测试、注册和认证机构, BSI 制定并颁布了第一部商业标准,并创立了全球最值得信赖和得到广泛认可的 ISO 系列管理体系,如今它已成为标准的代名词,并被世界超过 50 万个机构采用。目前被广泛运用的 ISO9000 、ISO 、ISO 及 OHSAS 均是由 BSI 颁布制定的质量管理体系 (BS5750) 、环境管理体系 (BS7750) 、信息安全管理体系 (BS7799) 和职业健康安全管理体系 (BS8800) 标准转化而来。这种绝无仅有的转化关系,是 BSI 作为标准制定、理解、诠释及认证服务方面的权威之源 。
      BSI 已向世界各国发放了 多分认证证书。 已有超过四分之一的“ 全球财富 500 强 ”企业和“ 金融时报指数 100 强 ”企业选择 BSI 为提供管理体系认证服务和培训服务。 BSI 在全球分支机构已达 180 多家,业务遍及欧洲 、中东、非洲、亚洲和美洲在内的110 多个国家,现已编撰标准 个,拥有享誉全球的认证标志。 BSI 是全世界认证机构中唯一被 ISO 组织委托进行标准研发及制定的认证机构,先后被英国的 UKAS 和美国的 ANAB 这两大认证机构认可。
      BSI 管理体系在20 世纪90年代初进入中国 , 并开始为中国大陆、香港、及台湾地区提供专业的管理体系认证服务和培训服务 , 目前已先后在香港、台湾、北京、上海、深圳、广州、重庆、大连、济南、厦门和南京等地设立了分支机构,并且仍在努力推动更多地区建立最佳规范 。 我们的目标是为任何致力于改善管理体系的中国地区机构提供无可匹敌的帮助。我们所拥有的国际地位和专业经验,为中国企业搭建了走向国际的桥梁 。
      要了解有关 BSI 的更多信息,请访问我们的网站: www.bsigroup.cn
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