Posted on Oct 12th 2019

Sr. Quality System Manager

中国,广东,珠海

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,广东,珠海

Full time

432721

保存职位

Job Title

Sr. Quality System Manager

Job Description

In this role, you have the opportunity to

  • Lead the Quality Management System (Medical Device related) at Philips Site Zhuhai, ensure that the Quality Management System is in compliance with the appropriate Philips Policies, standards and regulations required by the products supported.

You are responsible for

  • Define and maintain the Quality Management System structure to ensure compliance to Philips Policies, ISO 9001, ISO 13485, 21 CFR 820, Canadian Medical Devices Regulations (CMDR), EU Medical Device Regulations and China FDA/ Medical Device & GMP Regulations
  • Maintain, enforce, and manage 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 at all levels.
  • Establish the Philips Quality Management System (PQMS) and manages its deployment.
  • Ensure proper audit planning and schedule meets the requirements of internal policies and external regulations.
  • Establish and execute a transition plan for all QMS in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS.
  • Lead/participate in the maintenance of the quality documents until such time as they are determined to be no longer applicable as part of the PQMS transition.
  • Ensure the addition and management of any local QMS documents in line with the evolution of the PQMS.
  • Ensure training and training registration as per the QMS and generates training content for local QMS documents as necessary.

You are a part of

  • Philips Quality Management System- Operations Quality, headquartered in Amsterdam, Philips Personal Health team is made up of a highly talented and multi-national workforce that is approximately of 25,000 strong, and spans over 50 countries with sales in more than 100 countries.

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

  • Education: Bachelor’s degree in a scientific or technical field Work experience:
  • 7+ years of experience in the medical device industry
  • Experienced manager with a minimum of 5 years of experience leading teams and delivering on organizational objectives
  • Experience managing a team to deliver business application implementation projects, including experience as an active contributor on projects with scheduled deliverables.
  • Experience validating application activities
  • Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
  • Successful experience working with cross functional teams across multiple work locations
  • Competencies and Skills
  • Strong working knowledge of GMP’s and other US FDA and China FDA regulations
  • Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.
  • Proven analytical capabilities
  • Strong IT skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications.
  • Excellent communication, organizational and project management skills
  • Effective written and oral communications skills and computer skills required
  • Network oriented and able to interact with different business functions and can work within numerous systems
  • Work cooperatively in a team environment

In return, we offer you

  • Promising career in leading Healthcare MNC.

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 2.5 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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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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