长沙招聘

Job Description

In this role, you have the opportunity to

• Deploy and maintain quality management system, ensure the daily operation process to comply with China GMP/MAH, PQMS, internal policy, and all applicable standards and regulations.

  You are responsible for

• Maintains, enforces, and manages a compliant and effective MAH QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes.

• Fully deploy NMPA GMP/GSP requirements in local MAH QMS.

• Ensures proper audit planning and schedule of GC MAH QMS meets the requirements of internal policies and external regulations.

• Provide the trainings to concerned employees to understand the process, regulatory and quality requirements.

• Support Management representative in Quality Management Review within MAH scope.

• Drive continuous improvement in GC MAH QMS and collaborate with BG/BU/CM for interface process improvement.

  You are a part of

• Greater China Market quality team with international exposure.

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

  Education学历:

• Bachelor degree or above, BS in Science or equivalent.

• Technical background is essential.

  Experience工作经验:

• Minimum of 8 years experience working in disciplined regulated industry and in the application of ISO13485, China GMP and EU MDD/MDR(preferred).

• Experienced manager with a minimum of 5 years of experience leading teams and delivering organizational objectives.

• Experience in active medical device manufacturing site, particularly in leading GMP audit.

• Experience with working with NMPA, Shanghai NMPA is preferred.

• Experience as project manager is preferred.

  Competency and Skills 能力和技能:

• Well understanding with ISO13485 standards and China MD GMP, knowledge of EU MDR and FDA QSR is an advantage.

• Family with China NMPA, CIQ, consuming products related regulations.

• Excellent communication and interpersonal skills, especially in cross-function team work.

• Positive attitude, will to take the lead for the responsible projects. Can work under high pressure.

• Computer skills including database management, word processing and spreadsheets are also necessary.

• Good in written and spoken English and Mandarin

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。