医疗器械审核员(CCAA持证)居家办公

Great that you're thinking about a career with BSI!

Job Description

Auditor – Medical Devices – (CCAA qualification)

Location – any city in China(work from home)

Are you looking for a career where you can use your expertise to ensure patient safety?

 Do you want variety and exposure to different medical device manufacturers and cultures?

 Your next career could be as an auditor; or as we call them at BSI a Client Manager.

• Undertake management system assessments in accordance with BSI requirements.
• 依据BSI要求开展质量管理体系审核
•  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.
• 撰写审核报告，沟通审核发现，并确保客户理解审核结果和改进的方向，从而使客户按照要求进行纠正措施的改进。
• Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
• 依据BSI政策、流程和规定期限，对证书签发， 重签发或撤销提出推荐的建议。
• 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.
• 领导和指导审核组，保持优质的服务质量，在客户和团队内保持良好的工作关系。
• 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.
• 与部门团队密切合作，从而维系与客户的良好合作关系和发掘新的业务机会，提升现有客户的满意度。
• 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.
• 与部门团队密切合作，及时准确反馈重要信息，确保客户资料和记录的更新和完整，满足公司内部的要求。
• 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.
• 给予新入职， 资历尚浅或者对客户业务不熟悉的同事适当的培训和支持。
• Maintain and develop assessment skills and technical and management system standards knowledge.
• 不断提升审核技能和学习质量管理体系标准相关知识
• Provide technical support to clients through business development, sales and customer service staff
• 协助业务开发、销售和客服人员对客户进行技术支持。
• 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”.
• 作为BSI品牌形象大使，遵循公司政策，提供BSI服务形象， 帮助客户优化企业绩效，培植“追求卓越的习惯”。

Candidate specifications

任职资格

• Bachelor degree or above with medical device related major or an equivalent professional qualification in a relevant subject
• 本科或以上学历，医疗器械相关专业或相关从业经验

• A medical device professional with training and a working knowledge of *
• 具备以下医疗器械行业专业知识和工作经验
  • ISO 13485 & EU Medical Device CE Marking
  • ISO 13485 &欧盟医疗器械CE认证
  • Medical Devices Risk Management – ISO 14971
  • 医疗器械风险管理-ISO 14971
  • GHTF Basis Knowledge, Process validation, PMS & Vigilance system
  • GHTF基本知识，工艺认证，医疗器械上市后监测和医疗器械警戒系统
• Minimum 4 years working experience in the fields of medical device
• 至少4年以上医疗器械行业从业经验
• Sterilization experience and microbiologist is preferable.
• 有灭菌经验或微生物专家优先考虑
• IVD background and experience is preferable
• IVD背景和从业经验优先
• CCAA qualification is preferable
• 具有CCAA注册审核员资格者
• Commercial understanding of compliance industry, minimum 2 years quality system management
• 了解审核行业， 至少二年的质量管理工作经验
• Knowledge of business processes and application of quality management standards
• 熟悉了解业务流程和质量管理体系的运用
• Good verbal and written communication skills and an eye for detail
• 优秀的书面和口头表达能力， 工作认真仔细
• Be self motivated, flexible, and have excellent time management/planning skills
• 办事积极主动， 灵活变通，有良好的时间管理和组织规划能力
• Can work under pressure
• 能够承受压力
• Willing to travel on business intensively
• 适应经常出差
• An enthusiastic and committed team player
• 工作热诚， 富有团队合作精神
• Good public speaking and business development skill will be considered advantageous
• 有良好沟通能力和业务开发技巧者优先考虑

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.