Posted on Oct 12th 2019

Q&R Compliance Specialist

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

375287

保存职位

Job Title

Q&R Compliance Specialist

Job Description

In this role, you have the opportunity to

  • Further Enhance Compliance Management, to ensure that medical products are produced in compliance with Philips Excellence Process Framework (PEPF), Manufacturing Products QMS as well as applicable regulations (FDA, EU-MDR, cFDA, etc. ) and standards (ISO13485, ISO14971, etc.).

You are responsible for

  • Support and facilitate the department in enabling and ensuring that medical products are produced in compliance with Philips Excellence Process Framework (PEPF), Manufacturing Products QMS as well as applicable regulations (FDA, EU-MDR, cFDA, etc. ) and standards (ISO13485, ISO14971, etc.),
  • Set up/Improve End-to-End processes within the organization to realize product lifecycle management and build an effective “Compliance Monitoring Platform” to manage the compliance in the different phases (project initiated, design and development, manufacturing, delivery, service, etc.)
  • Give guidance to Manufacturing products team and actively contributes to all aspects related to quality, process and applicable regulatory requirements
  • Support QMS leader to 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.
  • Execute procedures for implementing CAPAs and Complaints/Feedback and for monitoring their effectiveness.
  • Contribute to QMS maintenance and improvement, and lead particular initiatives.
  • Support all QMS related trainings, provide the trainings to internal team, and build compliance knowledge succession plan

You are a part of

  • Professional and energetic site quality team. 

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

  • Education: Bachelor’s engineering or science degree
  • Experience: Minimum 5 years of experience in Quality, Project, and Process Engineering related function is required. Experience in the medical device industry (CFDA, EM MDR, and FDA) or highly regulated industries are highly preferred. Competency and Skills :
  • Familiar with Medical device regulations and standards (CFDA, 21 CFR 820, MDR, ISO13485, ISO14971)
  • Familiar with product lifecycle management processes
  • Strong interpersonal and influencing skills
  • Experience with working with cross-functional teams
  • Fluent oral and written English

 

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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(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)

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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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