Philips Senior Design Quality Engineer 

China, Jiangsu 

960742529

Senior Design Quality Engineer

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.