Posted on Oct 12th 2019

Sr. Design Quality Engineer

中国,江苏,苏州

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,江苏,苏州

Full time

426230

保存职位

Job Title

Sr. Design Quality Engineer

Job Description

In this role, you have the opportunity to

  • Maintain the quality management system compliance by ensuring the quality procedures are implemented and followed.
  • Supervise NPI (New Project Introduction) project, and implement design controls requirement into NPI.
  • Concentrate on CFR820.30 Design control and ISO13485, EU MDD/MDR, MDSAP, ISO 14971 Risk Management, IEC62304 Software development lifecycle, IEC60601, IEC62366 Usability Engineering and any other regulation/standard applied to medical device and be expert of the above regulations.

You are responsible to

  • Be responsible for the design control in NPI/Sustaining Project/lifecycle management  Quality Assurance. (Process)
  • Working with these cross-functional groups, develop quality engineering documentation independently, and lead their implementation. (Process & Product)
  • Defining and review quality and regulatory requirements for the product within design process. (Product)
  • Ensure product-development processes and documentation meet Quality System requirements in relevant regulations, e.g. CFR 820.30, China NMPA and ISO13485. Drive project decision direction toward compliance, cross functionally and globally. (Process)
  • Ensure that program documentation (Design History File) is created, controlled and archived in accordance with the Quality System. (Process)
  • Key member of product defect management board, engineering change board. (Product)
  • Key player for risk management activities for product development. (Product)
  • Conduct the project gate audits and consultant as needed to support project team for the project deliverables. Handle project related noncompliance accordingly. (Process & Product)
  • Find the improvement opportunity during project quality assurance and initialize the improvement for process and product quality/reliability/usability. (Process & Product)
  • Be expert of design control and lead Design Control process improvement and maintenance and Support QMS manager to promote Quality Culture. (Process)
  • Participates in the decision-making process of product-quality related decisions. (Product)
  • Provide the process training to required trainees. (Process)
  • Lead, prepare and participate/be main escort in internal and external audits (e.g. FDA, CFDA, TUV, JPAL, KFDA, MDSAP, etc) (Process)
  • Facilitate CAPA when design control related. (Process & Product)

You are a part of

You will become part of the Q&R organization, supporting the Business Unit Magnetic Resonance Imaging (MRI) within Philips Healthcare, who is passionate about serving our customers and making a meaningful contribution to (product) quality.

MRI is responsible for marketing, product development and lifecycle management of 1.5T and 3T High end and Mid-range performance.

You will be based in China. Work in cross-functional project (core) teams consisting of amongst others R&D, Service, Industrialization. In addition, you will have the ability to interact across different sites as a benefit of being part of a global organization.

To succeed in this role, you should have the following background, basic skills or experience

  • BS/MS in Engineering or equivalent experience
  • Strong quality assurance management experience, minimum 5 years in quality assurance
  • Strong design control and new product development experience
  • Strong statistical and analytical abilities (e.g. design for six sigma, design for reliability)
  • Professional knowledge in the area of ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP
  • Professional knowledge in product safety standards (e.g. IEC60601, IEC62366 Usability, etc)
  • Strong communication, problems solving and continuous improvement.
  • Fluent English both in writing and speaking.
  • Have experience in medical industry or high regulated industry (preferred)
  • Strong Influence Skill, Presentation Skill and Dispute solving Skills.

In return, we offer you

Challenging tasks on technical interesting and relevant Medical Device Products and/or accessories.

The opportunity to grow beyond initially assigned tasks/responsibilities for those with the right drive and skills.

A pleasant working environment with flexible working hours.

Our benefits are very competitive and designed around your preferences:

  • A market conform salary
  • A variable bonus based on both Philips results and personal performance
  • Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
  • Solid company pension scheme and attractive collective health insurance package
  • Opportunity to buy Philips shares and products with discount
  • Healthy work-life balance

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

Contact

If you forgot your password, you can click the Forgot Password  button on the Sign In screen to reset it.

将此发给朋友

您是否知道可能对这一职位有兴趣的人?将链接发送给朋友吧!

你不知道的飞利浦

Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.

观看视频

获得类似职位的通知

您将每周收到一次通知

* 我希望收到飞利浦工作提醒。 这是什么意思?

类似的工作

No similar jobs found