Posted on Oct 12th 2019

Sr. Design Assurance Quality Engineer for Service


Full time



Posted on Oct 12th 2019


Full time



Job Title

Sr. Design Assurance Quality Engineer for Service

Job Description

In this role, you can

Ensure full compliance, and solid quality on design assurance of services & integrated solutions, service tools and service components.

You are responsible for

• Responsible for design assurance activities of development projects in service and solution environment, to ensure it’s in compliant with applicable regulatory, standards and corporate requirements.

  • Align with sponsor and internal stakeholders on quality governance model for Service & Solution development projects,
  • Designing Quality plans for Service & Solution development per applicable QMS by project level tailoring of Product Development Launch and Maintenance processes and deliverables
  • overseeing the execution of Quality Plans for Service & Solution development
  • provide guidance to project team members on processes & template requirements, and reviewing Service & Solution development design deliverables,
  • identifying project quality risks & process gaps and drive mitigation
  • setting up, monitoring & analyze quality performance metrics of projects and convert them into actionable plan to drive project quality improvement,
  • leading root cause analysis on project’s key quality, compliance and process issues in CAPA process.
  • Responsible for deployment Product Development Launch and Maintenance for Service & Solution from corporate to local QMS
  • Supports organization’s Q&R processes, including quality training, internal & external audit and CAPA, Quality Management Review
  • Give guidance and actively contributes to other aspects related to quality, applicable regulatory requirements and corporate policies and procedures

You are a part of

Quality and regulatory organization of Chief Technology Office, who is providing quality system, quality engineering, and regulatory compliance governance to all R&D activities in China Innovation Hub.

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

  • 3+ years Q&R role in a Design Quality Engineering or verification engineering Role
  • 5+ years quality system/engineering role in medical device industry
  • 3+ years Experienced in service/solution creation/delivery role in medical device industry
  • Knowledge of applicable Medical Device product and service Lifecycle and QMS standards (ISO62304, ISO13485:2016, ISO14971) is a must
  • Result oriented, Team player, pragmatic & pro-active
  • English speaking/reading/writing

In return, we offer you

  • A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this Q&R role in a complex environment will open many doors for your long-term career.
  • You will have access to the most advanced cutting edged technologies within R&D projects (such as AI, API based health care eco-system, etc) and build up your Q&R capability in assuring quality and compliance of these new technologies with top talent in the industry globally.
  • 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.

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 2.5 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.




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