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Job Information

Philips Quality System Management Specialist in Shenzhen, China

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In this role, you have the opportunity to

  • Develop, implement and maintain QMS to ensure products and services are designed and produced to meet or exceeding customer requirements and expectation.

  • Actively participate with cross-functional teams in business and engineering discipline

  • Guide functional teams to always to do the right thing at the first time.

You are responsible for

  • Maintains, enforce, and manages a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes

  • Be accountable to manage and harmonize all QMS management processes and ensure compliance to FDA, MDD/EU-MDR , ISO 13485 and China GMP

  • Provide guidance to local team and actively contributes to all aspects related to quality, process and applicable regulatory requirements

  • Review and approve QMS documents and records, ensuring GDP compliance

  • Manage the transition /deployment of the PQMS and manage its deployment

  • Plan, coordinates, and execute internal QMS audits to ensure compliance with internal and external requirements and to identify and implement improvement opportunities within the organization.

  • Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.

You are a part of

  • Professional QMS Team, with multiple team peers globally.

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

  • Education: Bachelor degree.

  • Experience: At least 5 years of QMS management experience in medical industries is required

  • Competencies and Skills:

  • Good command of English and Chinese Language skill is required.

  • Be familiar with ISO 13485, ISO 9001, CRF 820 ,MDD 93/42/EEC or EU-MDR.

  • Excellent organization and coordination.

  • Experience of leading a team is preferred.

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.

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 .

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