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Q&R Leader, Shenyang

In this role, you have the opportunity to

• Lead the Quality and regulatory team in Philips Shenyang;

• Establish and maintain the QMS compliance, including CAPA, Management review, internal/external audit, Design review, post market surveillance

• Leadership role in PCC SY management team;

• Figure out the overall strategy on Q&R on the NPI and LCM.

• Improve the product quality @ quality Norm;

You are responsible for

• Responsible for customer complain handling by interface with field service

• Responsible for quality management system maintenance and update per the ISO13485, EU MDR, MDSAP, and FDA CFR 820 QSR.

• Responsible product risk management per ISO14971

• Leadership role with inclusion & diversity. Account for defining “what” with collaboration with other competency leader defining “How”.

• Leadership role sitting in Shenyang management team. and promote quality compliance culture.

• Responsible for the design control compliance and product design quality for NPI.

• Figure out the overall Q&R strategy for NPI project/products or LCM.

• Responsible for internal audit, external audit coordination and audit finding follow up.

• Responsible for QMS training planning, deployment and measurement for internal employees

• Participate the Philips corporate End2End project, PEPF and drive the transition plan, gap analysis, and implementation into local QMS.

• Responsible for CAPA system surveillance, drive the CAPA managed in a timely manner in company level and meet CAPA on time KPI.

• Quality statistic, Analysis and process continuous improvement

You are a part of

• Global Q&R team

To succeed in this role, you should have the following skills and experience

• BS/MS in Engineering or equivalent experience

• Experience on ISO13485 and FDA CFR820.

• Risk management per ISO14971

• EU MDD/MDR experience preferred

• Engineering bachelor degree preferred

• Typically requires a Bachelor’s degree with> 7 years of related experience in Quality

• Assurance; or a Master’s degree with <5 years of related experience in Quality

• Strong statistical and analytical abilities.

• Strong communication, problems solving and continuous improvement.

• Fluent English both in writing and speaking.

• Six Sigma Black Belt is preferred

• Image System Product service experience is preferred

• Have experience in medical industry is plus

In return, we offer you

We offer experiences and opportunities that add many unexpected and enriching moments to our employees’ lives. Especially when the innovative health technologies and solutions they help develop benefit their own friends and family.

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.