Quality System Management Specialist

Job Description

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.

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