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In this role, you have the opportunity to

• Maintain the quality management system compliance by ensuring the quality procedures are implemented and followed.

• Supervise NPI (New Project Introduction) project, and implement design controls requirement into NPI.

• Concentrate on CFR820.30 Design control and ISO13485, EU MDD/MDR, MDSAP, ISO 14971 Risk Management, IEC62304 Software development lifecycle, IEC60601, IEC62366 Usability Engineering and any other regulation/standard applied to medical device and be expert of the above regulations.

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.

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.