Senior QMS Engineer
飞利浦(中国)投资有限公司 Philips (China) Investment Co.,Ltd.
- 公司规模:10000人以上
- 公司性质:外资(欧美)
- 公司行业:多元化业务集团公司
职位信息
- 发布日期:2020-09-09
- 工作地点:上海-浦东新区
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 语言要求:英语良好
- 职位月薪:1.5-2万/月
- 职位类别:医疗器械生产/质量管理
职位描述
In this role, you have the opportunity to
Ensure the quality system requirements and agency regulatory requirements be fully followed and the processes are efficient and effective.
Ensure the CAPA process to be well implemented and can support the quality system and business continue improvement.
Ensure quality system complying with relevant international standards and relevant national regulations such as ISO13485, QSR, MDR, CGMP and MDSAP etc.
You are responsible for
Enables the transition/deployment of PQMS and manages its deployment
Ensure proper audit planning and schedule meets the requirements of internal policies and external regulations.
Local manages plan for all QMS parts in scope while maintaining a compliant and effective (local) QMS throughout the duration of the transition to the PQMS. Administers and contributes to the management of any local QMS documents in line with the evolution of the PQMS.
Supports training and training administration as per the QMS and contributes to training content for local QMS documents as necessary.
Contributes to the availability of metrics/KPI data to measure training effectiveness, PQMS deployment and QMS compliance.
Establishment of quality management system complying with identified standards and regulations, implementation and maintenance of quality management system in the organization
Integration and optimization of processes in quality management system to adopt Philips Ultrasound Business Group requirement
Initiate and facilitate CAPA process in the organization and follow up of agreed actions.
Cooperate with other stakeholders to support the CAPA investigation and get tasks done timely.
Organize the CAPA review meetings to monitor the CAPA phases and escalate any potential risk if have.
You are a part of
A professional site production & development quality team with international exposure.
To succeed in this role, you should have the following skills and experience
Education: Bachelor degree or above.
Experience: More than 5 years of experience in quality management field, more than 3 years of experience in Medical device manufacturing, more than 2 years in CAPA engineering/CAPA implementation.
Be family with quality tool of problem solving and or the CAPA/ 8D approach.
Be familiar with ISO13485, QSR, MDR, CGMP and MDSAP requirements.
Good quality engineering related tools knowledge and implementation skills.
Good team work spirit and communication skills.
Good skills of project management.
Good English skill.
In return, we offer you
We offer experiences and opportunities that add many unexpected and enriching moments to our employees’ lives. Especially when the innovative health technologies and solutions they help develop benefit their own friends and family.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
职能类别:医疗器械生产/质量管理
公司介绍
飞利浦公司总部位于荷兰,2021年销售额达172亿欧元,在全球拥有大约78,000名员工,销售和服务遍布世界100多个国家。公司目前在诊断影像、图像引导治疗、病人监护、医疗信息化以及消费者健康和家庭护理领域处于领导地位。
在飞利浦,每一个人,都至关重要。这是我们始终坚持的信念。在飞利浦,你将用数字化驱动有意义的创新,积极影响自己与数十亿人的生活,践行改善人类生活的使命。我们全心营造多元包容的工作环境,平等互助的工作氛围,让你的独特之处得到充分尊重和欣赏,鼓励你释放真我,以梦为马,不负韶华。本着 “立足中国,辐射全球” 的理念,我们通过布局广泛的业务线,为你带来广阔的平台、丰富的学习资源、多样的内部发展机会,助你成为具备全球化视野和本土深度的一专多能复合型稀缺人才。
创美好,做真我,迎蜕变。
我们深信每一个你都卓尔不凡, 更期待与志同道合的你笃行致远。
联系方式
- Email:ruby.chen@philips.com
- 公司地址:上海市静安区灵石路718号A1栋 (邮编:200233)
- 电话:13774217703