Posted on Oct 12th 2019

Advanced Quality Engineer

中国,上海,上海

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,上海,上海

Full time

373753

保存职位

Job Title

Advanced Quality Engineer

Job Description

In this role, you have the opportunity to

Evaluate, investigate, and resolve complaints while also analyzing complaint data and gathering additional information as needed. You will manage the complaint investigation process end-to-end. You will work with other teams in a collaborative environment to complete the end-to-end complaints process in a highly regulated environment.

You are responsible for

  • Evaluate, investigate, track and complete complaints through effective and established complaint handling processes.
  • Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
  • Participate and collaborate objectively with team members to achieve consistent processes while identifying process improvements to drive efficiency and compliance.
  • Review information provided from the call center, field organization and customer feedback systems and provide evaluation as to whether these service events constitute complaints.
  • Identify product characteristics and/or failures that could lead to death or serious injury.
  • Coordinate with team members in obtaining any missing information.
  • Collaborate with a variety of diverse persons such as Engineers, Scientists, Clinical Specialists, Field Service Engineers, Professional Customers and Manufacturing personnel to facilitate the complaint investigation process globally.
  • Review each complaint and determine eligibility for adverse event reporting to worldwide regulatory agencies.
  • Other Projects as assigned

You are a part of

General Specialty Care (GSC) is the home for our General Care solution containing non-acute, cardiology-specific and other specialty products, e.g: Spotcheck (Suresigns), Guardian; MR/Invivo (incl. Flexcardio); DECG, Holter, Cardiograph, Stress products.

  • 1+ year of post-market complaints experience in a medically regulated industry.
  • Bachelor’s degree in engineering, clinical sciences, related sciences, or relevant related experience
  • Proficiency using office tools such as Microsoft Office Suite and various other computer software applications.
  • Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR. Medical Device and or other regulated industry (Pharma, IVD,) preferred.
  • An organized, analytical thinker with exceptional attention to detail.
  • An excellent communicator, both written and verbal for coordinating with colleagues and regulatory authorities worldwide.
  • Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.
  • Must be able to work under pressure to meet regulatory reporting time frames and company requirements.
  • Experience in TrackWise or similar system is preferable.

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

•           A professional but fun workplace, a healthy work-life balance environment;

•           An energetic, genuine, inventive, supportive and dynamic team atmosphere;
 

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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If you have any other questions regarding the recruitment process please refer to our FAQs. In case of technical difficulties with the website, please send an email to careersite@philips.com. 
(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)

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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.

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