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    Quality Management System Specialist - Shenzhen, 中国 - Philips

    Philips background
    全职
    描述

    Job Title

    Quality Management System Specialist

    Job Description

    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


    •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.



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