长沙招聘

职位描述：
A. Main Purpose of the Role:
Responsible for developing, applying, revising, and maintaining the manufacturing quality activities.
Ensuring compliance the regulatory (FDA, CE, SFDA)/standard (ISO13485) requirements are implemented correctly and followed strictly.

B. Job Holder’s Profile Requirements
1. Bachelor Degree Or Above, major in Mechanical & Electronic Engineering or Equivalent
2. 5+ years Quality Engineering Experience in Medical Device/ Mechanical manufacturing
3. Familiar with medical device standard and regulatory requirement ISO13485, QSR, GMP .
4. Fluent English both in writing and speaking
5. Excellent communication and interpersonal skills;
6. Good training skills able to generate, following and explain detailed instructions and inspection procedures of the responsible areas accurately.
7. Problems solving Familiar with analytical tools, such as FMEA, process control plan
8. Solid knowledge/experience in SPC, GRR & Process Capability Analysis;
9. High morale with excellent work ethic, integrity and attitude.
10. Teamwork orientated, Self-motivated & able to Work Independently

Key Areas of Accountability:
1. Responsible for driving product quality improvement in operations.
2. Responsible for handling and determine Nonconformity products during manufacturing process.
3. Lead the project team to workout the control point from FMEA through control plan.
4. Design and Develop inspection process to cover in-process, final and package, DHR review before final release.
5. Contact Window to handle customer and market quality issue compliant and feedback
6. Responsible for Quality Data analysis and report provide by weekly/monthly/Quarterly.
7. Conduct Process Audit to drive continue improvement in ops.
8. Provide training on Quality Assurance/GMP/FDA-QSR related topics
9. Participate and support the Process Validation execution as needed.
10. Participate and supporting the external and internal Audit.
11. Other tasks assigned by manager. 举报 分享

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。