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.
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 .