In this role, you have the opportunity to

• The Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle.

• The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.

• The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes

You are responsible to

• Be responsible for the design control in NPI/Sustaining Project/lifecycle management Quality Assurance. (Process)

• Working with these cross-functional groups, develop quality engineering documentation independently, and lead their implementation. (Process & Product)

• Defining and review quality and regulatory requirements for the product within design process. (Product)

• Ensure product-development processes and documentation meet Quality System requirements in relevant regulations, e.g. CFR 820.30, China NMPA and ISO13485. Drive project decision direction toward compliance, cross functionally and globally. (Process)

• Ensure that program documentation (Design History File) is created, controlled and archived in accordance with the Quality System. (Process)

• Key member of product defect management board, engineering change board. (Product)

• Key player for risk management activities for product development. (Product)

• Conduct the project gate audits and consultant as needed to support project team for the project deliverables. Handle project related noncompliance accordingly. (Process & Product)

• Find the improvement opportunity during project quality assurance and initialize the improvement for process and product quality/reliability/usability. (Process & Product)

• Be expert of design control and lead Design Control process improvement and maintenance and Support QMS manager to promote Quality Culture. (Process)

• Participates in the decision-making process of product-quality related decisions. (Product)

• Provide the process training to required trainees. (Process)

• Lead, prepare and participate/be main escort in internal and external audits (e.g. FDA, CFDA, TUV, JPAL, KFDA, MDSAP, etc) (Process)

• Facilitate CAPA when design control related. (Process & Product)

You are a part of

You will become part of the Q&R organization, who is passionate about serving our customers and making a meaningful contribution to (product) quality.

To succeed in this role, you should have the following background, basic skills or experience

• BS/MS in Engineering or equivalent experience

• Strong quality assurance management experience, minimum 5 years in quality assurance

• Strong design control and new product development experience

• Strong statistical and analytical abilities (e.g. design for six sigma, design for reliability)

• Professional knowledge in the area of ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP

• Professional knowledge in product safety standards (e.g. IEC60601, IEC62366 Usability, etc)

• Strong communication, problems solving and continuous improvement.

• Fluent English both in writing and speaking.

• Have experience in medical industry or high regulated industry (preferred)

• Strong Influence Skill, Presentation Skill and Dispute solving Skills.

In return, we offer you

Challenging tasks on technical interesting and relevant Medical Device Products and/or accessories.

The opportunity to grow beyond initially assigned tasks/responsibilities for those with the right drive and skills.

A pleasant working environment with flexible working hours.

Our benefits are very competitive and designed around your preferences:

• A market conform salary

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

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

• Solid company pension scheme and attractive collective health insurance package

• Opportunity to buy Philips shares and 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. 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.