Product Quality Engineer
In this role, you have the opportunity to
- Develop and implement systems to ensure products or services are designed and produced to meet or exceed customer requirements and expectations.
- Participate in the change management process to assure the products or services continue to meet customer requirements.
- Participate with cross-functional team with other business and engineering disciplines. Establish the principles of product and service quality evaluation and control for the system, including design controls.
- Provide independent oversight and review of the project deliverables throughout the product lifecycle.
- Own responsibility for your decisions and actions, while also holding others accountable for the same.
You are responsible for
- Develop and implement quality programs, including design controls, launch, maintenance, tracking, and analyzing, reporting, and problem solving.
- Provide effective oversight to the execution of the Project Management Plan and any Risk Management activities
- Validate key design inputs including usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability.
- Review and assist in the development of verification and validation protocols and reports, including appropriate testing sample sizes.
- Design review (mandatory for SV and RFD phase, as one of core team members and independent reviewers)
- Overview reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools, and reporting so that the cross functional team follows design controls correctly.
- Understand and support the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up, focusing on the design control and related elements.
- Acquire and analyze data using appropriate quantitative methods to facilitate process analysis and improvements.
- Ensure quality and completeness of project design history files, risk management files, validation packages, and change orders.
- Provide ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes, and CAPA investigations.
- Engage in continuous improvement activities by identifying opportunities and recommending improvements to design and development process.
You are a part of
- The Philips Quality and Regulatory organization located in Shenzhen, China. Report to Product Quality Engineering Manager in Shenzhen. HPM is a dynamic business that provides Philips Healthcare customers with advanced lifesaving medical technology.
To succeed in this role, you should have the following skills and experience
- Bachelor or above Engineering Degree or equivalent experience
- At least 3 years’ experience in Quality field in highly regulated industries, such as Medical device, Automotive, Aerospace. Experience in Medical Devices industry and Design quality or QMS, CAPA related functions is highly preferred.
- Understand design controls and risk management methodologies and their applications
- Able to make tough, decisive decisions concerning the containment and disposition of product quality and product safety issues
- Understand problem-solving and quality improvement tools and techniques
- Strong English and Chinese language skills are required
- ASQ certified Quality Engineer (America Society for Quality) preferred
- Experience in Software Validation/Verification for regulated, embedded software/systems and processes is a plus
- Experience in Software quality for standalone and embedded software is a plus
- Have a working understanding of LEAN and six sigma concepts, methodologies and deployment is a plus
- Prefer for knowledge of project management.
- Strong logical thinking
- Excellent organization and coordination ability
In return, we offer you
- Sharpen your talents with new challenges in our dynamic organization. As a market-driven company, we’re used to listening to our customers & apply the same thinking to our employees. We offer a competitive salary, outstanding benefits and flexibility in a career with a positive and supportive atmosphere in which to develop your talents further.
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.
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.