成都招聘

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

• Assist Head of Q&R to implement Quality Management System in design, manufacturing , complaint handling of Quality control

• Develop quality management system strategy and plan according to business and technology development need

• Working together with each process on establishment and improvement of processes to fulfill quality system

• Ensure that production and process is strictly followed by team and all quality requirements are fulfilled;

• 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 CAPA managers or 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.

• Plan and organize management reviews, initiate continuous improvement process.

• Report on the performance of quality management system implementation; define necessary actions including resources to continuously improve the effectiveness of quality management system.

• Organize necessary quality (refresh) trainings for employees

• Act as a consultant for quality regulations in the organization and a coordinator for external audits

 

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 8 years of experience in quality management field, more than 5 years of experience in Medical device manufacturing, more than 3 years in CAPA engineering/CAPA implementation.

• Competencies and skills:

• 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.

• Very good English skill.

荷兰皇家飞利浦公司是一家领先的健康科技公司，致力于在从健康生活方式、疾病预防、到诊断、治疗和家庭护理的整个“健康关护全程”，凭借先进的技术、丰富的临床经验和深刻的消费者洞察，不断推出整合的创新解决方案，助力健康医疗系统实现四重目标——提高大众健康水平、提高医护人员满意度、改善患者体验，并降低关护成本。飞利浦的愿景是通过有意义的创新，令世界更健康、更可持续的发展，到2030年每年改善25亿人的生活。

        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。