长沙招聘

Job responsibilities:

· Maintain effective quality system to keep the company up to required level (ISO, QSR820, OHSAS etc.)

· Plan, lead and manage the internal audits activities for ISO9001 /ISO13485/QSR820/ISO14001/OHSAS18001, follow up the corrective and preventive action to make sure the system is well maintained;

· Plan, lead or support CL BMS project deploying in factory to fullfill FDA requirement, like software validation , DMS migration and TEDS system.

· FDA compliance management

· Manage and facilitate FDA mock inspection

· To conduct quality system gap analysis facilitate continuous improvement

· To work with manufacturing plant on vendor audit.

· To assist compliance of quality system procedures and validation protocols/reports

· CAPA management

· To organzie QMS training (ISO/QSR/FDA..etc.)

· To support the Management Review

Requirements:

· Bachelor’s Degree or above (with a pharmaceutial or medical device background or similar is is preferred)

· Knowledge in the areas of medical device, change control, CAPA, audit and risk managment.

· Knowledge of FDA (21 CFR Part 210 and 211) regulations

· A minimum of 5-year experience in a quality system/regulatory environment.

· Good understanding of ISO9001/ISO13485/QSR820 management system, total quality management concept

· Effective interpersonal and communication skills, detailed minded and able to work under pressure.

· Fluent written and spoken English

· Teamwork spirit.

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。