Posted on Oct 12th 2019

Sr. Software Quality Engineer


Full time



Posted on Oct 12th 2019


Full time



Job Title

Sr. Software Quality Engineer

Job Description

In this role, you can

Ensure full compliance, and solid product & process quality on design assurance of digital platform, Software as Medical Device, Health Informatics and software component.

You are responsible for

• Responsible for Software quality assurance activities of development projects to ensure their compliance with applicable regulatory, standards and corporate requirements.

  • Align with BU/internal customer on quality governance model for R&D projects,
  • designing SW Quality plans per local or BU QMS by project level tailoring of Product Development Launch and Maintenance / Architecture and Platform Creation processes and deliverables
  • overseeing the execution of SW Quality Plans,
  • provide guidance to project team members on processes & template requirements, and reviewing software 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 software tool validation to ensure the tools applied to product development, test and operation processes are fully validated to fulfill intended uses
  • Responsible for Non-Product Software System Validation in quality system to ensure the compliance with regulatory and corporate requirements
  • 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
  • Responsible for deployment of Architecture and Platform Creation and Product Development Launch and Maintenance from corporate to local QMS with QMS level tailoring for different project risk categories
  • Leading and coaching multiple Quality Engineers in large scale platform/software development program to ensure QE resources can be appropriately allocated to those key aspects of project
  • Define, deploy and optimize development processes and templates for projects with unique features (eg. AI/data driven algorithm)

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

  • 5+ years Q&R role in a Software/firmware Development Quality Engineering or verification engineering Role
  • 5+ years in Development Quality/testing role in medical device industry
  • Experienced in Scaled Agile preferred is a must
  • Knowledge of applicable Medical Device Software Product Lifecycle and QMS standards (ISO62304, ISO13485:2016, ISO14971) is a must
  • Experienced in AI (data driven) Algorithm Quality Assurance is a plus
  • 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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