高级质量法规经理招聘 - 浙江巴奥米特医药产品有限公司

A. 汇报对象Report line

VP QA/RC APAC

亚太区质量法规副总裁

B. 工作职责Job Description

· Direct reports would be the managers within the regulatory compliance department and quality assurance department.

直接汇报对象是法规部经理和质量保证部经理

· Manage regulatory compliance and quality assurance personnel including expenses/budgets and approves and establishes quarterly objectives.

管理法规和质量保证部门的人员，包括支出/预算以及批准和建立季度目标

· Performs and provides guidance and/or assist in defining, implementing and follow-up of systematic corrective and preventive actions (CAPA) and approves all CAPAs.

执行及提供指导及帮助，定义，实施和跟踪系统的纠正预防措施并批准纠正预防措施(CAPA)

· Support Regulatory Affairs as needed for domestic and international submissions from manufacturing perspective required by the US FDA, China CFDA and international submission in designated countries.

支持本地和国际法务工作，需要时支持中国和国际生产注册提交，以符合美国FDA及中国FDA和各国的要求

· Lead and host Notified body audit, governmental agency audit and Corporate Compliance Audits (US FDA, Notified Body, Brazilian GMP, JPAL, Korea MFDS GMP and other applicable regulations) as head of ZBiomet RC/QA.

作为浙江 Biomet质量法规的头，领导和主持认真审核，政府机构审核以及总部的质量合规审核（美国FDA, 认证机构，巴西GMP, 日本GMP, 韩国MFDS GMP以及其它相关的审核）

· Functions as Management Representative for ZB and lead the organizing, preparation and presenting at management review meetings.

担任金华Biomet的管理者代表，主导，准备管理评审并提供信息

· Responsible for the development and implementation of ZB QMS procedures, lead QMS Continual Improvement initiatives.

负责部署实施ZB的质量体系程序，领导质量体系的持续改善

· Support Quality Hold, Health Hazard Evaluation (Determination)s (HHE(D)) and coordinates on recall, MDR associated with ZBiomet as necessary.

支持质量隔离、健康危害评估(决定)(HHE(D)), 协调ZB的产品召回，MDR

· Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of the assigned product or component.

对所属的产品和部件，策划和执行分析，检验，设计，实验以及整合

· Ensures that statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.

保证实施SPC（统计过程控制）方法，评估现行过程和过程变化

· Support Supplier Quality Improvement activities by working closely with SQE and major suppliers; as well as participating in new supplier evaluation and Supplier related Quality Plan reviews and approvals as necessary

密切配合供应商质量工程师，支持供应商质量改善活动，需要时参与新供应商评估以及供应商相关的计划评审及批准

· Communicates significant issues or developments identified during quality activities and provides recommended process improvements to management.

与管理层沟通发现的重大问题和发展，并对过程改善提供建议

· Maintains a working knowledge of government and industry quality codes and standards.

具有并保持本行业的专业知识，领略对政府和行业的质量要求和标准

· Provides leadership and personnel for lean initiatives related to quality of product.

领导、发起并参与与人员和产品质量有关的精益活动

· Lead and develop RC/QA teams at ZBiomet to ensure sustainable and continual talent growth to fit business growth requirements.

领导发展 ZB RC/QA团队, 保证驼队的持续稳定发展和持续能力提升，满足业务增长的需求

C、资格要求Job Qualification:

§ Bachelor’s degree or higher is preferred.

学士或更高学位

§ 5 years of practical medical device manufacturing experience preferred. 

5年医疗器械生产经验

§ A working knowledge of US FDA and regulations and how to interpret and monitor them with experience or knowledge in Quality Systems relating to 21 QSR Part 820 and ISO 13485:2003, CFDA GMP, JPAL, Brazilian ANVISA GMP, Korea MFDS GMP and other applicable regulations

熟悉美国FDA及法规，并能详熟解释和监控美国法规的执行情况，具有21 CFR 820质量体系，ISO13485:2003, CFDA,JPAL, 巴西GMP, 韩国GMP以及其它国家的相关法规知识

§ Understanding and implementation experience in the following tools is required: 5S, kaizen, kanban, value stream management, poka-yokes, SMED, etc.

具有理解实施5S，Kaizen, 看板， 价值流管理，防呆，以及SMED的经验

§ Communication skills with cross functions and also inter companies on RC/QA related topics/ issues/ processes and projects.

有关RC/QA相关的事物，具有良好的内部沟通技巧和良好的跨部门沟通技巧

§ Computer skills required, including Microsoft Excel, PowerPoint and Word.

良好的计算机能力，熟悉Excel, PowerPoint和Word软件

§ Leadership skills to the RC/QA team on guiding, supporting and managing performance and skills.

具有良好的领导力，领导RC/QA团队，提供指导，支持能力发展和绩效管理，

§ Professional and ethical conduct

专业和职业精神

§ Committed to striving for quality excellence in the execution of required responsibilities

执行职责，专注质量优异

§ Committed to continuously improving English communication skills and cultural awareness

持续改善英语沟通能力和文化意识

§ Committed to continuously learning as needed to perform the required responsibilities

执行职责，专注学习自我提升