Posted on Oct 12th 2019

Complaint Handling Engineer, PD China


Full time



Posted on Oct 12th 2019


Full time



Job Title

Complaint Handling Engineer, PD China

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.
  • Concentrate on CFR820.198 complaint files, 820.803 MEDICAL DEVICE REPORTING, 820.806 MEDICAL DEVICES, EUMDR, ISO13485, ISO14971 and global regulation’s requirement.
  • Handling complaints from Installed Base, and adverse event reporting.

You are responsible for

  • Customer complaint handling by interface with Service/ Engineering team;
  • Drive the customer complaint resolve by working with cross functions;
  • Responsible for adverse event reporting to applicable Competent Authority;
  • Evaluate the risk level with R&D team for complaint hazardous situation per Product Risk Management Files
  • Drive Complaint handling process optimization and implementation
  • Organize Complaint periodic review and work with cross function to facilitate Complaint closure

You are a part of

  • Reports to Complaint Handling Manager

Work relationship

Internal: major functions such as R&D, manufacturing, purchasing etc.

External: regulatory agencies such as US FDA, China NMPA and notify bodies such as TUV

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

  • BS/MS in Engineering or equivalent experience
  • Strong quality assurance management experience, minimum 5 years
  • Strong Post Market surveillance and experience, including complaint handling, adverse event reporting.
  • Strong statistical and analytical abilities.
  • Imaging System Product experience is preferred
  • Strong communication, problems solving and continuous improvement.
  • Fluent English both in writing and speaking.
  • Experience in medical industry is plus

In return, we offer you

We offer experiences and opportunities that add many unexpected and enriching moments to our employees’ lives. Especially when the innovative health technologies and solutions they help develop benefit their own friends and family.

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.


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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.




* 我希望收到飞利浦工作提醒。 这是什么意思?


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