Posted on Oct 12th 2019

Quality Engineer, Risk Management

中国,广东,深圳

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,广东,深圳

Full time

440937

保存职位

Job Title

Quality Engineer, Risk Management

Job Description

In this role, you have the opportunity to

  • Be a key developer in expanding our Quality & Regulatory Risk Management team for our Connected Care organization.
  • Create and implement new tools and methods to manage risk, which will contribute to the safety and efficacy of medical products that save lives and improve health.

You are responsible for

  • Collaborate at a systems level with R&D, Clinical, Data Analysis, and other key functions to develop a quantitative approach to risk management.
  • Demonstrate expertise by leading cross-functional teams to identify risks, implement risk control measures, and document a robust and living Risk Management File.
  • Facilitate the creation of both top-down and bottom-up risk management tools, assessments, processes, and principles, including a FMEAs.
  • Conduct analysis of existing similar products from the company and competitor products to provide documented compliance and evidence of State of the Art, as part of periodic risk management file updates.
  • Assure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures.
  • Ensure the systematic and logical conversion of customer requirements to product specifications and post market surveillance codes.
  • Create and continually improve procedures and work instructions to ensure reliable, repeatable results.
  • Support ongoing compliance improvement initiatives, including CAPAs across the five business groups in Connected Care.

    You are a part of

  • An organization that believes-what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you’ll find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It’s our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.

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

  • BS in Engineering or a related field. MS preferred.
  • 4+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry, medical device industry preferred. 2+ years’ experience with a MS. Degree or higher.
  • Extensive hands on experience with the ISO 14971 standard-nice to have
  • Knowledge of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.
  • Strong understanding of risk management requirements, tools, methodologies, and processes, including use of a variety of accepted methods-nice to have
  • Demonstrated expertise in managing complex projects and implementing cultural change.
  • Excellent customer service and interpersonal communication skills, including regularly leading presentations in front of peers and leadership.
  • Experience working within a Quality Management System.
  • Green Belt or Black Belt certification preferred.
  • Excellent team work skills including influencing and building rapport with internal customers and stakeholders.
  • Good English and Chinese language skills required

    In return, we offer you

  • The opportunity to use your data analytic skills to support products which provide lifesaving diagnostics and therapy.  A chance to grow your professional skills in an environment that values diverse ideas and creative approaches.

          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.

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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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