Posted on Oct 12th 2019

Sr. QMS Engineer

中国,上海,上海

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,上海,上海

Full time

371626

保存职位

Job Title

Sr. QMS Engineer

Job Description

Senior QMS Engineer

Location: Shanghai

In this role, you have the opportunity to

  • Ensure the quality system requirements and agency regulatory requirements be fully followed and the processes are efficient and effective.
  • Ensure the CAPA process to be well implemented and can support the quality system and business continue improvement.
  • Ensure quality system complying with relevant international standards and relevant national regulations such as ISO13485, QSR, MDR, CGMP and MDSAP etc.

You are responsible for

  • Enables the transition/deployment of PQMS and manages its deployment
  • Ensure proper audit planning and schedule meets the requirements of internal policies and external regulations.
  • Local manages plan for all QMS parts in scope while maintaining a compliant and effective (local) QMS throughout the duration of the transition to the PQMS. Administers and contributes to the management of any local QMS documents in line with the evolution of the PQMS.
  • Supports training and training administration as per the QMS and contributes to training content for local QMS documents as necessary.
  • Contributes to the availability of metrics/KPI data to measure training effectiveness, PQMS deployment and QMS compliance.
  • Establishment of quality management system complying with identified standards and regulations, implementation and maintenance of quality management system in the organization
  • Integration and optimization of processes in quality management system to adopt Philips Ultrasound Business Group requirement
  • Initiate and facilitate CAPA process in the organization and follow up of agreed actions.
  • Cooperate with other stakeholders to support the CAPA investigation and get tasks done timely.
  • Organize the CAPA review meetings to monitor the CAPA phases and escalate any potential risk if have.

You are a part of

  • A professional site production & development quality team with international exposure.

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

  • Education: Bachelor degree or above.
  • Experience: More than 5 years of experience in quality management field, more than 3 years of experience in Medical device manufacturing, more than 2 years in CAPA engineering/CAPA implementation.
  • Be family with quality tool of problem solving and or the CAPA/ 8D approach.
  • Be familiar with ISO13485, QSR, MDR, CGMP and MDSAP requirements.
  • Good quality engineering related tools knowledge and implementation skills.
  • Good team work spirit and communication skills.
  • Good skills of project management.
  • Good English skill.

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.

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你不知道的飞利浦

Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.

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