Posted on Oct 12th 2019

Sr. Quality Assurance Manager

中国,广东,深圳

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,广东,深圳

Full time

420207

保存职位

Job Title

Sr. Quality Assurance Manager

Job Description

In this role, you have the opportunity to

  • Plan and execute the quality management system related activities and support innovation teams on the site.

You are responsible for

  • Formulate and implement the Business’ long-range quality and compliance policy.
  • Create Quality awareness level as determined within the organization.
  • Enforce (a simplified) quality systems and harmonize them across the Businesses and Cluster sites; establish an effective Management Review process, including routine reporting.
  • Lead the Philips QMS (PQMS) related deployments and implementations.
  • Ensure the addition and management of any local QMS documents in line with the evolution of the PQMS.
  • Manage site training Matrix and training assignments.
  • Ensure training and training registration as per the QMS and generates training content for local QMS processes as necessary.
  • Manage and facilitate the CAPA process and the audits on the site
  • Support Documentation & Change control process
  • Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
  • Manage compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
  • Manage the review and approval of finished products manufactured for and by the company in accordance with their approved specifications. Includes Complaint handling.
  • Manages all inspections and questions relating to the operation of the manufacturing sites in coordination with all other applicable company groups.
  • Manage product recall activities to include recall policies and procedures for the company. Additionally, manage product-compliant activities and processes.
  • Direct the Audit Program for the organization.
  • Draft and manage the strategic improvement processes (‘breakthrough Program’) in the Business (One Page Strategy, Hoshin Plan).
  • Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation.
  • Support on the L4L and L4G initiatives for involved businesses.

You are part of

  • The Philips business group Personal Health which delivers innovative lifestyle solutions for personal well-being. Our brand promise delivers innovation that matters to you, meaning that our products are caring, innovative & impactful.
  • The global QMS team and reports to QMS Lead in Eindhoven.

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

  • Bachelor’s degree or above, major in Engineering related discipline is preferred
  • Solid experience (10 years+) working in quality related functions, experience in MNCs/Medical industry is preferred
  • Strong experience with ISO 9001, ISO 13485, CFDA,
  • Understanding and application of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR 820, EU Medical Device Directive (93/42/EEC), European Medical Device Regulation MDR 2017/745, ISO 13485, and MDSAP (including all member countries regulations).
  • Ability to interact professionally with all organizational levels
  • Must be results-driven - Able to manage competing priorities in a fast-paced environment
  • Ability to communicate ideas and information clearly, effectively, and concisely
  • Highly detailed oriented with strong organization and prioritization skills
  • Good command of English and Chinese language skills required

             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.

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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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