Posted on Oct 12th 2019

Senior Quality Engineer

中国,江苏,苏州

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,江苏,苏州

Full time

400147

保存职位

Job Title

Senior Quality Engineer

Job Description

QMS Engineer


In this role, you have the opportunity to

Be a part of team of build a high growth business that will help improve the lives of millions of millions of people around the world, while advancing Philips digital transformation journey as a global leader in Health Technology.

You are responsible for

  • Responsible for establish and maintain the QMS according requirement from ISO13485, US FDA 21 CFR part 820, MDSAP, EU MDR, Brazil GMP, Japan J-PAL, China NMPA GMP etc.
  • Lead Philips Excellence Process Framework (PEPF) Process, E2E project deployment in site QMS
  • Responsible for driving product quality improvement in operations.
  • Responsible for handling Nonconformity products during manufacturing process.
  • Lead the project team to work out the control point from FMEA through control plan.
  • Design and Develop inspection process to cover in-process, final and package, DHR review before final release.
  • Lead cross function team to investigate the produce or process issues and drive improvements.
  • Contact Window to handle customer and market quality issue including compliant and feedback
  • Responsible for Quality Data analysis and report provide by weekly/monthly/Quarterly. 
  • Conduct Process Audit and implement lean mythology to drive continuous improvement in operation.
  • Provide training on Quality Assurance related topics
  • Participate and support the Process Validation execution as needed.
  • Participate and supporting the external and internal Audit.
  • Other tasks assigned by manager.

You are a part of

A progressive and energetic team that contributes directly to the growth of the business. You have a direct reporting line to the Factory Quality Leader.

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

  • BS/MS degree or equivalent in Engineering or equivalent experience.
  • Strong quality management experience, minimum 5+ years relevant experience with 3+ year in medical industry quality control or in a similar field.
  • Evidence of practical knowledge of standards and regulations pertaining to the medical device industry. This includes but is not limited to FDA, CFDA, ISO13485, MDD, JPAL, Brazil GMP, etc
  • Proficiency with quality system management is preferred.
  • Knowledge and experience in quality control disciplines (e.g. production and process quality control, design quality control, post market surveillance quality control) is advantageous.

Skills:

  • Demonstrated experience in leading cross-functional teams for problem solving, with excellent team- work spirit.
  • Project management skill or lean methodology to introduces new QMS requirements /processes to the organization. 
  • Strong written, verbal, and interpersonal skills while communicating in both English and Chinese.
  • Good document writing skills, including clear logic and quality & regulatory compliance.

In return, we offer you


A path towards your most rewarding career. Philips is growing its technical capability enterprise wide. Succeeding in this QMS Engineer role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise.

Our benefits are very competitive and designed around your preferences:

• We offer a market conform salary

• A variable bonus based on both Philips results and personal performance

• Convenient working conditions in office

• Extensive set of tools to drive your career, such as a personal development budget, free training and coaching

• Attractive collective health insurance package

• Opportunity to buy Philips products with discount

• Healthy work-life balance

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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