Posted on Oct 12th 2019

Advanced Design Quality Engineer

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

383342

保存职位

Job Title

Advanced Design Quality Engineer

Job Description

In this role, you have the opportunity 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

    

  • 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
  • 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: At least 3 years’ experience in Design quality engineering, Experience in design and development quality management for Class II & III active medical device is preferred

• Fluent in English and Chinese Languages is required.

• Competencies and Skills:

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

• Appropriate 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

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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