东莞招聘

In this role, you have the opportunity to

• Prepares and executes the Global Quality & Regulatory policy, by initiation and coordination of related activities throughout all disciplines in order to make the Philips a premier company in safety and compliance.
• Establish the vision and strategy for business management and quality systems, and practices to ensure consistent, standardized execution of Philips Excellence Process Framework processes.
• Lead and handle Quality activities in the Greater China Market. This includes responsibilities for Post Market Surveillance, Quality System Management and Supplier Quality Engineering Management.

You are responsible for

• Acting as the management representative for all key regulatory agencies for product safety and quality (e.g: China NMPA). Developing and maintaining an effective working relationship with NMPA and other regulatory bodies.
• Dedicatedly ensuring all auditable facilities consistently operate in a state of compliance to meet applicable regulations (e.g: NMPA GSP requirements, etc) and inspection readiness.
• Attracting, developing, engaging and retaining your team members. You drive ambition towards our vision, act as a coach and co-own the career development plans of your subordinates.
• Developing organizational policies and authorizes their implementation.
• Providing direction to senior managers in various areas, groups, and/or operations.
• Timeliness of PMS activities (closure of complaints, safety/reporting, FCO/FSN, responses to customers & authorities).
• Effectiveness & Timeliness of CAPA.

PMS(Post Market Surveillance):

• Processing and administration of customer feedback & complaints, safety reporting, medical vigilance reporting, coordination of FSN/FCO.
• Interacting with local government agencies for the PMS events to respond queries from local regulatory agenda regarding Philips products.

QMS(Quality Management System):

• Ensuring compliant and effective QMS are maintained, especially the compliance with NMPA regulatory requirements.
• Conducting management review periodically by collecting quality metrics/KPIs.
• Ensuring proper audit plan and schedule meet the requirements of internal policies and external regulations.
• Driving the continuous improvement and promote the quality culture cross Greater China.
• Hosting regulatory inspections conducted by agency investigators and directing the formal response to any negative findings.

SQE(Supplier Quality Engineering):

• 3rd-party product quality management.
• Closely working with SQA function for supplier management and 3rd party product qualification.

You are a part of

• Global Q&R team, you will directly report to the Head of Regulatory & Clinical Affairs for HealthTech Business.

To succeed in this role, you should have the following skills and experience

• Master degree, preferably in a life-scientific discipline, and a minimum of 10 years of experience working in quality and regulatory affairs organization within global medical device industry.
• Deep understanding of MDD, MedDev’s, FDA QSR’s, ISO 13485, and Greater China applicable regulations.
• Experience with Research and Development, Sales and Service, Manufacturing, Marketing, IT, Document and Data Management, Purchasing/Procurement, Logistics and Service/Installation.
• An advanced degree in management is strongly preferred.
• Shown leadership in formulating and implementing global strategies to ensure compliance with applicable regulations to improve product market access.
• Validated experience in understanding consequences of new and changing regulations in Greater China & business groups, expertly transferring this to all applicable partners to ensure timely compliance and guaranteeing continuous market access.
• Proven experience in successfully representing organizations in industry associations.
• Experience to lead and develop strategies for a multi-site, global healthcare business while also being able to design and execute specific projects and lead teams.

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。