Posted on Oct 12th 2019

QMS 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

474257

保存职位

Job Title

QMS Manager

Job Description

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

  • Looking at the challenges the world is facing today, Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
  • Ensure that the Quality Management System is created in compliance with the appropriate Philips Policies, standards and regulations required by the products supported.
  • Support in the Quality Management Planning activity of changes to ensure compliance, outsourcing and Philips programs
  • Act on required reporting to respective regulatory and notified bodies for such activities as site registrations, device licenses, changes in product types, changes in activities at the site, and changes in personnel.

You are responsible for

Be accountable to manage and harmonize all QMS management processes and ensure compliance to FDA, EU-MDR, ISO 13485 and China GMP Provide guidance to cross function 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 applicable procedures and monitor its implementation 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. Ensure proper planning and schedule of regulatory reporting meets the requirements of internal policies and external regulations.

You are a part of

  • QMS Team, report to Sr. QMS Manager.

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

  • Bachelor’s degree in a scientific or technical field
  • Experience:
  • 5+ years of experience in the medical device industry
  • Strong working knowledge of GMP’s and other FDA regulations
  • 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.
  • Competency and Skills:
  • Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.
  • Strong IT skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications.
  • Proven analytical capabilities
  • Excellent communication, organizational and project management skills
  • Good English and Chinese language skills are required

In return, we offer you

  • A path towards your most rewarding career.

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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

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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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