Posted on Oct 12th 2019

Advanced Design Quality Engineer


Full time



Posted on Oct 12th 2019


Full time



Job Title

Advanced Design Quality Engineer

Job Description

In this role, you have the opportunity to

  • Lead Shenzhen Design Quality Engineering team to ensure that design meets compliance standards, quality management system and regulatory requirements
  • Be responsible for Verification & Validation activities (planning, execution and deliverable) review and approval for confirming design outputs comply with requirements of design inputs.

You are responsible for

  • Be responsible for leading Shenzhen ECR design quality Engineering  team to ensure that design meets compliance standards, reliability and quality management system requirements
  • Ensure design processes compliance to PQMS procedures/work instructions, including local process/procedure development as appropriate.
  • Be responsible for quality planning of local design control management system e, transfer and maintenance.
  • Design review (mandatory for SV and RFD phase, as one of core team members and independent reviewers)
  • Take part in Risk (SRA/DRA/PSRA) assessment as risk management team member
  • Be responsible for Verification  &Validation activities (planning, execution and deliverable) review and approval for confirming design outputs comply with requirements of design inputs.
  • Be responsible for change request review, including judgement for final disposition of defect tracking
  • Be responsible for DHF Review
  • Ensure the of deliverable Design transfer sufficiency and effectiveness
  • Be responsible for Design and/or Device Master Record change review & approval
  • Independently produces and completes Quality Engineering Documents
  • Be responsible for performing timely, quality engineering tasks like: Assessing quality plans, assessing product design and reviewing test and other performance data, analyses market feedback, lead root cause analysis and quality problem solving.
  • Product quality improvement and assist in problem solving

You are a part of

•Professional DQE Team, with multiple team peers globally.

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

• Education: Bachelor degree, major in science or engineering discipline is preferred.

• Experience: More than 5 years’ experience in quality engineering or quality management in medical device industry. At least 3 years of leading a team.

• Fluent in English and Chinese Languages is required.

• Competencies and Skills:

• Be familiar with medical device regulatory and standards, especially for MDD 93/42/EEC or EU-MDR, QSR part 820, China GMP and ISO 13485.

• Has Strong awareness of medical device industrial standard, such as IEC60601, GB9706 and ISO 14971

• Be familiar with product design and development process & critical phase, prefer for IDP or CMMI etc.

• Be familiar with typical control measures and methodology for design quality and product quality, prefer for DFSS or GB.

• Prefer for knowledge of project management.

• Strong logical thinking

  • Excellent organization and coordination ability

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.

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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