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Philips Quality & Regulatory Compliance Specialist in Shanghai, China


In this role, you have the opportunity to

Work as member of Philips quality and regulatory professionals, contribute to Quality Management System of Philips CTO

You are responsible for

  • Ensure CTO China organizations' QMS compliance in accordance with Philips Policy, as well as applicable worldwide regulations and standards, identify and implement improvement opportunities within the organization.

  • Lead particular initiatives, include PEPF processes and software application/tool deployment.

  • Lead/participant QMS internal audits as leader auditor/auditor, facilitate corporate level 2 audits and external audits.

  • Execute procedures for implementing CAPAs, Complaints/Feedback, Risk Management and for monitoring their effectiveness.

  • Supports training as per the QMS and contributes to training content for QMS documentation as necessary.

  • Provide support and coaching to CTO China teams with regard of Quality and Compliance.

  • Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others

You are a part of

CTO China Quality Team

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

  • Bachelor’s engineering or science degree

  • Minimum of 6 years’ experience in Medical Device Design and Development, Manufacture or commercial organization , At least 3 years’ experience acting in a quality/regulatory role and with focus on software

  • ISO 13485/ISO9001 internal auditor

  • Familiar with Medical device regulations and standards, especially medical device software

  • Knowledge and experience with Agile methodology, including but not limited to SAFe model

  • Strong interpersonal and influencing skills as well as analytical/Statistical skills

  • Experience with working with cross-functional teams

  • Fluent oral and written English

  • Working knowledge with the IEC62304, ISO 14155 or ISO 62366 standards is preferred

  • Working knowledge with Software FMEA is preferred

In return, we offer you

A path towards your most rewarding career. Philips is transferring to Digital Healthcare enterprise wide. Succeeding in this role in a complex environment will open doors for your long term career, in quality and regulation, or clinical science areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

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 at . 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 at on our career website, where you can read stories from our employee blog at . Once there, you can also learn about our recruitment process at , or find answers to some of the frequently asked questions at .