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Job Information

Philips Advanced PQMS Engineer in Suzhou, China

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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 the Pressure Vessel registration in EU, USA, China, including the registration file submission, communication with regulatory authorities and certification body.

  • Responsible for establish and maintain the QMS according requirement from regulatory requirement for Pressure Vessel in each country , including the PED, ASME certification, etc.

  • Responsible for incorporate pressure vessel QMS into existing Medical QMS to meet the requirement form ISO13485, US FDA 21 CFR part 820, MDSAP, MDR etc.

  • Introduces regulatory / QMS requirements that are new for the organization. Lead Regulatory/QMS projects with cross functions, works independently and provides consultative advice within specific functional areas.

  • Annual plan internal audit program, driving internal auditor qualification, schedule internal quality system audit activities, and audit finding response.

  • Overall coordinate corporate, third party audit and regulatory agency inspections, include audit planning, audit execution, and audit finding response.

  • Maintain the quality management system compliance by ensuring the quality procedures are implemented and followed, initiate QMS process improvement as required.

  • Other task assigned by line 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 PQMS Manager.

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 8+ years relevant experience with 5 + year in Pressure Vessel industry or in a similar field.

  • Practical knowledge of Pressure Vessel regulations (such as PED, ASME certificate)

  • Practical knowledge of standards and regulations pertaining to the medical device industry is preferred. This includes but is not limited to FDA, CFDA, ISO13485, EU MDR, JPAL, Brazil GMP, etc,

  • Proficiency with regulatory registration / quality system management is preferred.

  • Knowledge and experience in quality and regulatory control disciplines is advantageous.

Skills:

  • Demonstrated experience in leading cross-functional teams for problem solving, with excellent team- work spirit.

  • 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 PQMS 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 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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